A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348(6) Compared With Co-administration of CKD-828, D097, and D337 in Healthy Adult Volunteers

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(6).

开始日期2024-01-04

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT05881707 / Completed临床1期

A Randomized, Open-label, Single Dose, 4-period Replicate Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-828 in Healthy Volunteers Under Fasting Conditions

A clinical trial to compare the pharmacokinetic and safety of CKD-828 20/1.25mg

开始日期2023-07-04

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

100 项与左旋氨氯地平/替米沙坦相关的临床结果

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100 项与左旋氨氯地平/替米沙坦相关的转化医学

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100 项与左旋氨氯地平/替米沙坦相关的专利（医药）

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项与左旋氨氯地平/替米沙坦相关的文献（医药）

Drug Design, Development and Therapy3区 · 医学

Pharmacokinetic and bioequivalence study of a telmisartan/S-amlodipine fixed-dose combination (CKD-828) formulation and coadministered telmisartan and S-amlodipine in healthy subjects

3区 · 医学

ArticleOA

作者: Kang, Woo Youl ; Cho, Seungil ; Ohk, Boram ; La, Sookie ; Yoon, Young-Ran ; Lee, Hae Won ; Yang, Dong Heon ; Kim, Bo Kyung ; Seong, Sook Jin ; Gwon, Mi-Ri ; Kim, Hyun-Ju

PURPOSEA new fixed-dose combination (FDC) formulation of telmisartan 80 mg and S-amlodipine 5 mg (CKD-828) has been developed to increase convenience (as only one tablet is required per day) and improve treatment compliance.METHODSThe pharmacokinetic characteristics and tolerability of an FDC of telmisartan and S-amlodipine were compared to those after coadministration of the individual agents in this randomized, open-label, single-dose, two-way, four-period, crossover study. To analyze the telmisartan and S-amlodipine plasma concentrations using a validated liquid chromatography-tandem mass spectrometry method, serial blood samples were collected up to 48 hours post-dose for telmisartan and 144 hours post-dose for S-amlodipine, in each period.RESULTSForty-eight healthy subjects were enrolled, and 43 completed the study. The mean peak plasma concentration (C_max) and the area under the plasma concentration-time curve from time 0 to the last measurement (AUC_0-t) values of telmisartan were 522.29 ng/mL and 2,475.16 ng·h/mL for the FDC, and 540.45 ng/mL and 2,559.57 ng·h/mL for the individual agents concomitantly administered, respectively. The mean C_max and AUC_0-t values of S-amlodipine were 2.71 ng/mL and 130.69 ng·h/mL for the FDC, and 2.74 ng/mL and 129.81 ng·h/mL for the individual agents concomitantly administered, respectively. The geometric mean ratio (GMR) and 90% confidence interval (CI) for the telmisartan C_max and AUC_0-t (FDC of telmisartan and S-amlodipine/concomitant administration) were 0.8509 (0.7353-0.9846) and 0.9431 (0.8698-1.0226), respectively. The GMR and 90% CI for the S-amlodipine C_max and AUC_0-t (FDC/concomitant administration) were 0.9829 (0.9143-1.0567) and 0.9632 (0.8798-1.0546), respectively. As the intrasubject variability of the C_max for telmisartan administered individually was 42.94%, all 90% CIs of the GMRs fell within the predetermined acceptance range. Both treatments were well tolerated in this study.CONCLUSIONCKD-828 FDC tablets were shown to be bioequivalent to coadministration of the individual agents with the respective strength, in healthy subjects under fasting conditions. There was no significant difference in safety profile between the two treatments.

Drug Design, Development and Therapy3区 · 医学

Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study

3区 · 医学

ArticleOA

作者: Hwang, Kyung-Kuk ; Cha, Tae-Joon ; Youn, Ho-Joong ; Yoon, Jung Han ; Kim, Sang-Hyun ; Yoon, Namsik ; Jeon, Hui-Kyung ; Lee, Nae-Hee ; Hong, Taek-Jong ; Ihm, Sang-Hyun ; Jo, Sang-Ho

PURPOSETo evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy.PATIENTS AND METHODSEligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.RESULTSAfter the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg (P<0.0001/P<0.0001), CKD-828 2.5/80 mg (P<0.0001/P<0.0001), and S-amlodipine 2.5 mg (P<0.0001/P=0.0027) groups, respectively, which were all significant BP reductions. At Week 8, the CKD-828 2.5/40 mg (sitDBP/SBP: P=0.0002/P<0.0001) and CKD-828 2.5/80 mg (sitDBP/SBP: P=0.0001/P<0.0001) showed superior BP-lowering effects to S-amlodipine 2.5 mg (P<0.001). At Week 4, all groups showed significant antihypertensive effects but both CKD-828 combinations (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) exhibited superior BP-lowering effects to that of S-amlodipine 2.5 mg (sitDBP/SBP: P=0.0028/P=0.0001 and P<0.0001/P=0.0012, respectively). The adverse event incidence was significantly lower in the CKD-828 2.5/40 mg (9.52%, P=0.0086) than in the S-amlodipine 2.5 mg group (27.87%) and increasing the telmisartan dose induced no unexpected adverse events, suggesting the safety of CKD-828.CONCLUSIONCKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.

100 项与左旋氨氯地平/替米沙坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	C09DB04	-

研发状态

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适应症	国家/地区	公司	日期
高血压	韩国	Chong Kun Dang Pharmaceutical Corp.	2013-01-31

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适应症	最高研发状态	国家/地区	公司	日期
原发性高血压	临床3期	中国	江西施美药业股份有限公司	2024-07-23
慢性肾病	药物发现	韩国	Chong Kun Dang Pharmaceutical Corp.	2019-10-23
血脂障碍	药物发现	韩国	Chong Kun Dang Pharmaceutical Corp.	2019-10-23