A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.

开始日期2023-12-21

申办/合作机构

Spero Therapeutics, Inc.

[+1]

NCT05856747 / Completed临床1期

An Open-Label, Single-Center, Single-Period Study to Compare Two Bioanalytical Assays for Tebipenem Following Administration of Oral Tebipenem Pivoxil Hydrobromide in Healthy Adult Volunteers

The primary purpose of the study is to compare the concentrations of tebipenem (TBP), the active moiety of tebipenem pivoxil hydrobromide (TBP-PI-HBr), as determined by two bioanalytical assays, a whole blood assay and a plasma assay, following a single oral dose of TBP-PI-HBr 600 milligram (mg) tablets in healthy adult participants.

开始日期2023-05-04

申办/合作机构

Spero Therapeutics, Inc.

NCT05121974 / Recruiting临床2期

Tebipenem-pivoxil as an Alternative to Ceftriaxone for Clinically Non-responding Children With Shigellosis: a Randomized Non-inferiority Trial

Background (brief):
Shigellosis is the second leading cause of death due to diarrheal diseases worldwide (>200,000 deaths/year). Though the mortality rate associated with Shigellosis has decreased, the fact that the bacteria have acquired resistance to multiple antibiotics, is a cause for major concern. Oral azithromycin and intravenous ceftriaxone are the recommend first and second line therapies, respectively in Bangladesh. Approximately 20% of Shigella isolates are resistant to azithromycin suggesting that a substantial number of children will require second-line therapy. While resistance to ceftriaxone in shigellosis is low in Bangladesh at 5%, the potential for rapid emergence of antibiotic resistance to this third-generation cephalosporin and ceftriaxone's resource-intensive delivery method, underscore the need for evidence-based alternative antibiotic regimens for multidrug resistant Shigella infections
Hypothesis:
Children treated with tebipenem-pivoxil will have no worse clinical and microbiologic failure rates compared to ceftriaxone.
Primary Aim To determine whether tebipenem-pivoxil is clinically non-inferior to the currently WHO-recommended second line Shigella therapy (ceftriaxone) 3 days after treatment initiation.
Hypothesis: Children randomized to tebipenem-pivoxil experience no more clinical failures than children treated with ceftriaxone 3 days after treatment initiation.
Secondary Aim:
To determine whether tebipenem-pivoxil is clinically non-inferior to the currently WHO-recommended second line Shigella therapy (ceftriaxone) 7 and 30 days after treatment initiation.
To determine whether tebipenem-pivoxil is microbiologically non-inferior to the currently WHO-recommended second line Shigella therapy (ceftriaxone) 7 and 30 days after treatment initiation.
Describe the number of adverse events, between children with shigellosis treated with oral tebipenem-pivoxil or IV ceftriaxone.
Compare the prevalence of ceftriaxone and carbapenam resistance, as well as ESBL-and carbapenemase-producing Escherichia coli, in children treated with tebipenem-pivoxil or ceftriaxone 7 and 30-days after initiation of second-line therapy.
Methods:
Investigators propose a phase IIb randomized controlled trial (RCT) to determine the efficacy and safety of oral tebipenem-pivoxil, compared to IV ceftriaxone, for children with Shigella infections unresponsive to first-line antibiotic therapy. Bangladeshi children aged 24 to 59 months with suspected Shigella infections and no clinical improvement within 48 hours of first-line therapy will be randomized to a 3-day course of oral tebipenem-pivoxil (4 mg/kg 3x daily) or 3-days of IV ceftriaxone (50 mg/kg 1x daily). The children will be evaluated for key clinical, microbiologic, and safety outcomes during the subsequent 30-day period. Additionally, investigators propose a lead in study of 15 patients to confirm the safety profile and pharmacokinetics and efficacy of tebipenem in the study population. During this pharmacokinetic study period investigators will compare 15 children with oral Tebipenem randomizing with 15 children with oral Azithromycin arm. Investigators will also check invitro susceptibility of Tebipenem-pivoxil in 200 shigella isolates prior to the clinical trial in collaboration with Infectious Diseases Division, icddr,b.
Randomization Block randomization (1:1) in random sized blocks of will be used to assign treatment groups at study enrollment by an independent statistician. Treatment allocation (once assigned) will be known to the managing clinician and the participant due to the differing drug delivery mechanisms of the two antibiotics (oral vs. injectable). However, the team conducting the statistical analyses will be blinded to treatment allocation (allocation will appear A and B).

开始日期2022-08-18

申办/合作机构

International Centre for Diarrhoeal Disease Research, Bangladesh

[+2]

100 项与替比培南酯相关的临床结果

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100 项与替比培南酯相关的转化医学

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100 项与替比培南酯相关的专利（医药）

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133

项与替比培南酯相关的文献（医药）

2024-04-02·Journal of Antimicrobial Chemotherapy

Do dietary interventions exert clinically important effects on the bioavailability of β-lactam antibiotics? A systematic review with meta-analyses

Review

作者: Paśko, Paweł ; Wiesner, Agnieszka ; Zagrodzki, Paweł

AbstractBackgroundManaging drug–food interactions may help to achieve the optimal action and safety profile of β-lactam antibiotics.MethodsWe conducted a systematic review with meta-analyses in adherence to PRISMA guidelines for 32 β-lactams. We included 166 studies assessing the impact of food, beverages, antacids or mineral supplements on the pharmacokinetic (PK) parameters or PK/pharmacodynamic (PK/PD) indices.ResultsEighteen of 25 β-lactams for which data on food impact were available had clinically important interactions. We observed the highest negative influence of food (AUC or Cmax decreased by >40%) for ampicillin, cefaclor (immediate-release formulations), cefroxadine, cefradine, cloxacillin, oxacillin, penicillin V (liquid formulations and tablets) and sultamicillin, whereas the highest positive influence (AUC or Cmax increased by >45%) for cefditoren pivoxil, cefuroxime and tebipenem pivoxil (extended-release tablets). Significantly lower bioavailability in the presence of antacids or mineral supplements occurred for 4 of 13 analysed β-lactams, with the highest negative impact for cefdinir (with iron salts) and moderate for cefpodoxime proxetil (with antacids). Data on beverage impact were limited to 11 antibiotics. With milk, the extent of absorption was decreased by >40% for cefalexin, cefradine, penicillin G and penicillin V, whereas it was moderately increased for cefuroxime. No significant interaction occurred with cranberry juice for two tested drugs (amoxicillin and cefaclor).ConclusionsFactors such as physicochemical features of antibiotics, drug formulation, type of intervention, and patient’s health state may influence interactions. Due to the poor actuality and diverse methodology of included studies and unproportionate data availability for individual drugs, we judged the quality of evidence as low.

2024-04-01·The Lancet Microbe

Effect of tebipenem pivoxil hydrobromide on the normal gut microbiota of a healthy adult population in Sweden: a randomised controlled trial

Article

作者: Melnick, David ; Eckburg, Paul B ; Giske, Christian G ; Camporeale, Angela ; Rosenborg, Staffan ; Nowak, Michael ; Razavi, Mohammad ; Sewunet, Tsegaye ; Critchley, Ian A ; Gasink, Leanne B ; Nord, Carl Erik

BACKGROUNDAntimicrobials cause perturbations in the composition and diversity of the host microbiome. We aimed to compare gut microbiome perturbations caused by oral tebipenem pivoxil hydrobromide (a novel carbapenem) and by amoxicillin-clavulanic acid (an orally administered β-lactam-β-lactam inhibitor combination widely used in clinical practice).METHODSWe did a phase 1, single-centre, randomised, parallel-group, active-control trial to evaluate the effect of tebipenem pivoxil hydrobromide on the human gut microbiota. Healthy participants aged 18 years or older with no documented illnesses during recruitment were enrolled at Karolinska University Hospital (Stockholm, Sweden). Study participants were stratified by sex and block-randomised in a 1:1 ratio to treatment with either tebipenem pivoxil hydrobromide (600 mg orally every 8 h) or amoxicillin-clavulanic acid (500 mg amoxicillin and 125 mg clavulanic acid orally every 8 h). The study included 10 days of treatment (days 1-10) and four follow-up visits (days 14, 21, 90, and 180). The trial was open-label for clinical investigators and patients, but masked for microbiology investigators. Faecal samples were collected at all visits. Sequencing of 16S rDNA was used to measure the diversity metrics, and quantitative culture to quantify selected taxa. The primary outcomes were changes in the α and β diversity and log count of colony-forming units for selected taxa between samples compared with baseline (day 1), and whether any changes reverted during the follow-up period. The analyses were done in the intention-to-treat population. This study was registered with ClinicalTrials.gov (NCT04376554).FINDINGSThe study was conducted between Jan 23, 2020, and April 6, 2021. 49 volunteers were screened for eligibility, among whom 30 evaluable participants (14 men and 16 women) were assigned: 15 (50%) to the tebipenem pivoxil hydrobromide group and 15 (50%) to the amoxicillin-clavulanic acid group. Baseline characteristics were similar between groups. Complete follow-up was available for all participants, and all participants except one completed treatment as assigned. The diversity metrics showed significant changes from baseline during the treatment period. Significant decreases in richness were observed on days 4-10 (p≤0·0011) in the amoxicillin-clavulanic acid group and on days 4-14 (p≤0·0019) in the tebipenem pivoxil hydrobromide group. Similarly, evenness was significantly decreased during treatment in the amoxicillin-clavulanic acid group (day 4, p=0·030) and the tebipenem pivoxil hydrobromide group (days 4-10, p<0·0001) compared with baseline. Quantitative cultures showed significant decreases in Enterobacterales (days 4-7, p≤0·0030), Enterococcus spp (days 4-14, p=0·025 to p<0·0001), Bifidobacterium spp (days 2-4, p≤0·026), and Bacteroides spp (days 4-10, p≤0·030) in the tebipenem pivoxil hydrobromide group. Similarly, in amoxicillin-clavulanic acid recipients, significant changes were observed in Enterobacterales (days 4-10, p≤0·048), Bifidobacterium spp (days 2-4, p≤0·013), and Lactobacillus spp (days 2-4, p≤0·020). Samples from the follow-up period were not significantly different from those at baseline in β diversity analysis (PERMANOVA, p>0·99). By the end of the study, no significant change was observed compared with baseline in either group. There were no deaths or severe adverse events.INTERPRETATIONThe impact of tebipenem pivoxil hydrobromide on the gut microbiome was similar to that of amoxicillin-clavulanic acid. The safety of antibiotic use with regard to the microbiome should be given attention, as dysbiosis is associated with health and disease.FUNDINGSpero Therapeutics.

2024-03-01·Drugs in R&D

Bioequivalence Study of Tebipenem Pivoxil in Healthy Chinese Adults

Article

作者: Lin, Sisi ; Bian, Li ; Wu, Yi ; Shao, Yiming ; Zhang, Yiwen ; Hao, Rui

BACKGROUND AND OBJECTIVETebipenem pivoxil (TP) is a carbapenem and is applied against pneumonia, otitis media, and sinusitis. This study compared the pharmacokinetics (PK) and safety of a test (T) preparation and reference (R) preparation of TP in healthy Chinese adults.METHODSThis study was a single-center, randomized, open, single-dose (fasting/postprandial) oral administration, two-agent, two-sequence, two-cycle, crossover bioequivalence trial. A total of 60 participants were enrolled (24 fasting and 36 postprandial). All participants were randomly assigned to the TR sequence and RT sequence. Subsequently, they switched T sequences or R sequences 7 days later. PK blood samples were collected according to the protocol, plasma TP concentration was determined by liquid chromatography-mass spectrometry, main PK parameters were calculated based on a non-compartment model, and adverse events were recorded during the test.RESULTSIn the feeding arm, the geometric mean ratio of maximum concentration (C_max) was 89.84% (90% confidence interval 84.33-95.70), the geometric mean ratio of area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC_0-t) was 86.80% (83.62-90.10), and the geometric mean ratio of area under the plasma concentration-time curve from time 0 to infinity time of quantifiable concentration (AUC_0-∞) was 86.90% (83.73-90.20), which were within the acceptable range of bioequivalence (80-125%). In the fasting arm, the geometric mean ratio of C_max was 96.07% (89.62-102.99), the geometric mean ratio of AUC_0-t was 93.09% (90.47-95.78), and the geometric mean ratio of AUC_0-∞ was 93.09% (90.48-95.77), which was within the acceptable range of bioequivalence (80-125%). Hence, the T preparation and R preparation of TP had bioequivalence in the fasting arm and feeding arm of the clinical trial. In addition, all adverse events were mild, and no severe adverse events were noted.CONCLUSIONPreparations T and R of TP were bioequivalent in the fasting and postprandial groups in clinical trials, and TP was safe.

101

项与替比培南酯相关的新闻（医药）

2024-05-08

·GlobeNewswire-Health Care

Spero Therapeutics to Report First Quarter 2024 Financial Results and Provide Business Update on Wednesday, May 15, 2024

CAMBRIDGE, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will report its first quarter 2024 financial results and provide an update on its business and pipeline on Wednesday, May 15, after the market close. The Company does not intend to host a conference call, and anticipates resuming quarterly earnings calls at the time it announces second quarter 2024 results. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset, clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections. Spero Therapeutics is developing its wholly owned lead product candidate, SPR720 as a novel oral, first-line treatment for nontuberculous mycobacterial pulmonary disease (NTM-PD), currently advancing in a Phase 2A proof of concept study. NTM-PD is a rare pulmonary disease caused by non-tuberculous mycobacterial infections. Tebipenem HBr is an investigational oral drug advancing in a Phase 3 registrational trial for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories. SPR206 is an innovative, investigational IV-administered direct-acting next generation polymyxin that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies. An Investigational New Drug (IND) application has been cleared by the FDA to advance SPR206 into a Phase 2 clinical trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia. For more information, visit https://sperotherapeutics.com. Investor Relations Contact:Ashley R. RobinsonManaging Director, LifeSci Advisors, LLCarr@lifesciadvisors.com(617) 775-5956 Media Inquiries: media@sperotherapeutics.com

临床2期引进/卖出临床3期财报

2024-04-17

·Firstwordpharma

GSK shares promising data for gepotidacin antibiotic in gonorrhoea

GSK on Wednesday spelled out more details on a positive Phase III trial of its investigational antibiotic gepotidacin as a potential new treatment for uncomplicated urogenital gonorrhea.The roughly 600-patient EAGLE-1 trial, which was toplined earlier this year, met its primary endpoint. Gepotidacin achieved a 92.6% microbiological success rate and demonstrated non-inferiority to the leading combination of intramuscular ceftriaxone plus oral azithromycin, which had 91.2% success rates.Safety and tolerability of gepotidacin in EAGLE-1 was similar to findings from earlier Phase I and II trials. Adverse events were typically mild or moderate, with the most common side effects being gastrointestinal. There was one severe and one serious event in the gepotidacin arm, although both cases were considered unrelated to the drug. Results will be presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) at the end of the month.Rising drug-resistant infectionsChris Corsico, head of development at GSK, said, "These results highlight the potential of gepotidacin as a new oral treatment option given the rising incidence of gonorrhoea worldwide, including drug-resistant infections." Each year, about 82 million new cases of gonorrhoea occur worldwide, and there has been a 118% increase in reported cases in the US from 2009 to 2021, with about half resistant to at least one antibiotic.Analysts at Barclays recently highlighted gepotidacin's dual-targeting mechanism against the DNA gyrase and topoisomerase IV enzymes as a key advantage in overcoming antibiotic resistance. They project peak sales could reach £801 million ($996 million) for the first-in-class antibiotic, if approved.Beyond EAGLE-1, GSK has also reported positive Phase III data from the EAGLE-2 and EAGLE-3 trials evaluating gepotidacin for uncomplicated urinary tract infections (uUTI). The company is gearing up for regulatory submissions; it expects to file for uUTI next half, followed by a submission for urogenital gonorrhoea in 2025.GSK had previously targeted its uUTI filing by mid-2023, but told FirstWord on Wednesday that it is "working with the FDA, ahead of submission, to include additional non-clinical data requested by FDA to support its filing package."Elsewhere in its antimicrobials pipeline, GSK struck a licencing deal with Spero Therapeutics in 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated UTIs. And last year, it partnered with Scynexis on the antifungal Brexafemme (ibrexafungerp) to treat vulvovaginal candidiasis (VVC) and reduce the incidence of recurrent VVC.

临床结果临床3期临床1期合格传染病产品

2024-04-17

·BioSpace

GSK Touts Late-Stage Antibiotic Win in Gonorrhea, Long-Term Shingrix Vaccine Data

Pictured: GSK's headquarters in London/iStock, William Barton GSK’s infectious disease unit reported two clinical trial victories Wednesday, lifting the lid on its Phase III antibiotic victory and sharing long-term data on its blockbuster Shingrix shingles vaccine. The Phase III antibiotic trial tested gepotidacin in uncomplicated urogenital gonorrhea. The molecule is a first-in-class oral candidate that inhibits bacterial DNA replication using a novel mechanism of action and binding site, suggesting it may be active against strains of gonorrhea and other pathogens that are resistant to existing antibiotics. GSK reported positive top-line results from the study in February 2024 without sharing any data. The drug developer has now filled in some of the blanks, revealing two oral doses eliminated the bacterial cause of gonorrhea in 92.6% of patients. The success rate was non-inferior to the 91.2% achieved by an existing antibiotic combination of intramuscular ceftriaxone plus oral azithromycin. The safety and tolerability data were similar to the Phase I and II results, GSK said. Gastrointestinal issues were the most common adverse event in the gepotidacin arm. One patient experienced a severe, Grade III adverse event but it was ruled unrelated to gepotidacin. The other adverse events in the gepotidacin cohort were mild or moderate, according to the company. GSK ran the study to unlock the market for treating gonorrhea, the rate of which increased by more than 100% in the U.S. from 2009 to 2021, according to the Centers for Disease Control and Prevention. The CDC received reports of almost 650,000 cases in 2022. Around half of U.S. cases are resistant to one antibiotic. GSK previously reported positive data from a pair of Phase III gepotidacin trials in uncomplicated urinary tract infection. With gepotidacin showing promise in two settings, GSK has identified the drug candidate as one of three anti-infectives that could collectively generate peak annual sales of £2 billion ($2.5 billion). The other anti-infectives are tebipenem HBr and Brexafemme. The anti-infectives could join a portfolio of products that includes Shingrix, a shingles vaccine that pulled in sales of £3.4 billion ($4.2 billion) last year. GSK is forecasting Shingrix sales of more than £4 billion ($5 billion) this year. GSK strengthened the case for Shingrix Wednesday. The company posted data from an extension to two Phase III trials, one in adults aged 50 years and over and another in people aged 70 years or older. Between the sixth and eleventh years after vaccination, Shingrix achieved a cumulative efficacy of 79.7% in the over 50s. Cumulative vaccine efficacy in people aged 70 years or older was 73.1%. “With the vaccine now included in many national immunization programs around the world, these data add to the body of evidence on the extended long-term protection against shingles and provide further confidence to inform public immunization strategies,” Phil Dormitzer, head of vaccines R&D at GSK, said in a statement. The immunization rate in people aged 50 years and over in the U.S. is 35%. While that leaves room to increase Shingrix sales in the U.S., GSK expects most of the growth in 2024 to come from overseas. The vaccine is approved in almost 40 countries, but penetration is less than 4% in most markets. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

临床结果临床3期疫苗上市批准临床2期

100 项与替比培南酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09598	替比培南酯	J01DH06	-

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中耳炎	日本	Meiji Seika Pharma Co., Ltd.	2009-04-22
肺炎	日本	Meiji Seika Pharma Co., Ltd.	2009-04-22
鼻窦炎	日本	Meiji Seika Pharma Co., Ltd.	2009-04-22

未上市

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适应症	最高研发状态	国家/地区	公司	日期
社区获得性肺炎	临床3期	中国	江苏柯菲平医药股份有限公司	2017-02-27
急性肾盂肾炎	临床2期	-	Spero Therapeutics, Inc.	2019-06-03
急性肾盂肾炎	临床前	塞尔维亚	Spero Therapeutics, Inc.	2019-06-03
复杂的尿路感染	药物发现	美国	Spero Therapeutics, Inc.	2021-10-28
急性肾盂肾炎	药物发现	匈牙利	Spero Therapeutics, Inc.	2019-06-03
急性肾盂肾炎	药物发现	美国	Spero Therapeutics, Inc.	2019-06-03
急性肾盂肾炎	药物发现	摩尔多瓦	Spero Therapeutics, Inc.	2019-06-03
急性肾盂肾炎	药物发现	斯洛伐克	Spero Therapeutics, Inc.	2019-06-03
急性肾盂肾炎	药物发现	捷克	Spero Therapeutics, Inc.	2019-06-03
急性肾盂肾炎	药物发现	南非	Spero Therapeutics, Inc.	2019-06-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04178577 (Pubmed \| Antimicrob Agents Chemother)	临床1期	肾功能不全	39	Tebipenem Pivoxil Hydrobromide (Cohort 1 (normal renal function))	廠範夢鏇製願夢壓廠積(製鬱鏇餘築壓簾餘觸憲) = 網獵簾窪製鬱願鑰範願繭淵鑰獵醖遞鬱願願製 (醖齋壓鬱繭鏇獵醖積糧 ) 更多	-	2022-04-14
				Tebipenem Pivoxil Hydrobromide (Cohort 3 (moderate renal impairment))	鏇製積膚顧餘鹽網網廠(艱繭顧簾窪蓋膚範餘積) = 獵網簾淵繭窪憲鑰構遞鏇範廠窪鑰餘醖糧願選 (衊窪製鬱鬱齋顧憲鬱醖 )
PD32-03 (AUA2022)	N/A	泌尿道感染	-	Tebipenem	鬱製繭廠壓鹽糧築壓襯(廠醖積夢鑰鹽製遞糧窪) = 鬱窪襯獵獵餘淵憲鏇鏇鹽窪餘蓋艱製觸壓糧簾 (網鑰築齋繭艱襯壓範鏇 )	-	2022-05-01
NCT03788967 (ADAPT-PO, Pubmed \| Br Dent J)	临床3期	复杂的尿路感染	1,372	Tebipenem pivoxil hydrobromide	(繭餘網窪顧範鑰製夢築) = 願鑰鹹遞簾蓋齋艱艱醖醖鬱憲鑰繭鹽繭艱窪鹹 (齋繭壓衊觸鏇鑰窪鹽範 ) 更多	积极	2022-04-07
				Intravenous ertapenem	(繭餘網窪顧範鑰製夢築) = 網積淵壓構壓構積獵鏇醖鬱憲鑰繭鹽繭艱窪鹹 (齋繭壓衊觸鏇鑰窪鹽範 ) 更多
NCT03788967 (CTgov)	临床3期	复杂的尿路感染 \| 急性肾盂肾炎	1,372	Dummy Infusion+TBPM-PI-HBr (TBPM-PI-HBr 600 mg)	蓋顧鬱築顧遞鏇壓顧廠(憲壓淵憲夢艱蓋簾憲製) = 觸餘獵獵築鬱夢鏇襯醖繭鏇廠餘選襯網願窪衊 (醖獵觸積選範鏇淵觸積, 膚鬱糧鑰獵衊餘鏇膚遞 ~ 壓窪糧糧鏇醖願鬱壓廠) 更多	-	2022-07-25
				Dummy tablets+Ertapenem (Ertapenem 1 g)	蓋顧鬱築顧遞鏇壓顧廠(憲壓淵憲夢艱蓋簾憲製) = 夢鹹衊壓淵顧繭願選鬱繭鏇廠餘選襯網願窪衊 (醖獵觸積選範鏇淵觸積, 膚糧衊淵獵築蓋艱醖餘 ~ 選製製選簾衊繭積簾選) 更多
NCT03788967 (ADAPT-PO, GlobeNewswire) 人工标引	临床3期	泌尿道感染 \| 急性肾盂肾炎	1,372	tebipenem HBr	(積願鹽衊醖鹹餘鏇遞鏇) = 餘鏇壓顧餘襯糧蓋鹹獵膚壓夢襯獵簾積夢廠構 (膚蓋餘鏇鏇鹹淵醖範築 ) 更多	非劣	2020-09-08
				Ertapenem Sodium	(積願鹽衊醖鹹餘鏇遞鏇) = 壓壓蓋鑰觸鹽積餘選壓膚壓夢襯獵簾積夢廠構 (膚蓋餘鏇鏇鹹淵醖範築 ) 更多