Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection.

Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, derived from Lactobacillus acidophilus and Bifidobacterium animalis, in standard therapy for the eradication of Helicobacter pylori infection.

开始日期2024-07-03

申办/合作机构

Ibsa Farmaceutici Italia Srl

NCT06193577 / RecruitingN/A

Single-centre, Prospective, Randomized, Placebo-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of a Food Supplement Based on Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters

Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.

开始日期2023-11-08

申办/合作机构

Ibsa Farmaceutici Italia Srl

[+1]

NCT05989984 / RecruitingN/A

Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement With Orodispersible Formulation vs an Iron Supplement in Capsules in Subjects With Mild Anemia

The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.

开始日期2023-08-04

申办/合作机构

Ibsa Farmaceutici Italia Srl

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0 项与 Ibsa Farmaceutici Italia Srl 相关的专利（医药）

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项与 Ibsa Farmaceutici Italia Srl 相关的文献（医药）

2023-07-28·Gels (Basel, Switzerland)

Restoring Adipose Tissue Homeostasis in Response to Aging: Initial Clinical Experience with Profhilo Structura^®.

Article

作者: Cigni, Clara ; Cassuto, Daniel ; Schiraldi, Chiara ; Bellia, Gilberto

The aim of the case series was to determine the efficacy of a new medical device developed for adipose tissue restoration in the face. The medical device used the patented NAHYCO^® Hybrid Technology to deliver 45 mg of high- (1400 ± 200 kDa) and 45 mg of low- (100 ± 20 kDa) molecular-weight hyaluronan, in 2 mL. Patients and methods: Twenty-two volunteers, aged 36-60 years. Two mL of Profhilo^® Structura was injected using a 25 G cannula for each hemiface, into superficial fat compartment along the line from the preauricular area to the mandibular angle. Two injections were performed, and Profhilo Structura's effect on restoring adipose tissue was evaluated immediately after treatment, and over a 6-month follow-up. The studied medical device revealed a pseudoplastic behavior and consistency that allowed easy extrusion from a syringe. It showed a lower viscosity compared to dermal fillers, based on crosslinked HA. Clinically, the soft tissue thickness increased immediately after injection, and the clinical improvement persisted across a 6-month follow-up. The self-reported satisfaction with the treatment showed an amelioration in the midface of all the subjects enrolled, with no adverse effects. Profhilo^® Structura demonstrated a peculiar fat compartment integration, with a regenerating effect on adipose tissue senescence. The skin thickening and compaction effects were similar to those obtained using chemically crosslinked dermal fillers, while a natural look was preserved, and the use of crosslinking agents was avoided.

2022-02-01·Clinical drug investigation4区 · 医学

Comparative Bioavailability Study of a New Vitamin D3 Orodispersible Film Versus a Marketed Oral Solution in Healthy Volunteers

4区 · 医学

Article

作者: Giori, Andrea Maria ; Caverzasio, Carol ; Radicioni, Milko ; Rovati, Stefano ; Cupone, Irma ; Marra, Fabio ; Mautone, Giuseppe

BACKGROUND AND OBJECTIVE:

An orally disintegrating film (ODF) formulation of vitamin D3 that dissolves rapidly in the mouth without drinking or chewing may be a worthwhile alternative to currently available drug products for therapeutic vitamin D supplementation. This study aimed to compare the bioavailability of a single dose of a vitamin D3 25000 I.U. ODF with those of a marketed oral vitamin D3 preparation in healthy subjects.

METHODS:

This Phase 1, randomised, parallel-group, open-label study compared the pharmacokinetics of calcifediol [25(OH)D3], the precursor of bioactive vitamin D3, after a single dose of a new vitamin D3 25,000 I.U. ODF with those of a Reference formulation (vitamin D3 25000 I.U./2.5 mL oral solution) in healthy adult subjects using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. The primary objective was bioavailability under fed conditions, defined as maximum plasma concentration (C_max) of 25(OH)D3 and area under the concentration-time curve from time zero to time t, the last quantifiable concentration (AUC_0-t). The pharmacokinetics of 25(OH)D3 were also evaluated following the ODF administration under fasting conditions. Subjects were randomised to receive a single dose of the vitamin D3 25000 I.U. ODF or the Reference oral solution under fed conditions or the vitamin D3 ODF under fasting conditions.

RESULTS:

Forty-eight healthy subjects were randomised and completed the study. Overall, the pharmacokinetic profile was very similar across the three treatment groups, and bioavailability did not significantly differ among treatments. Under fed conditions, mean 25(OH)D3 plasma values for C_max were 6.68 ± 2.03 versus 6.61 ± 2.62 ng/mL for the Test versus Reference formulations. Corresponding values for AUC_0-t were 2364.80 ± 1336.97 versus 2150.52 ± 1622.76 ng/mL × h. Mean C_max was slightly lower (6.68 ± 2.03 vs 7.23 ± 1.48 ng/mL) and the time to reach peak concentration was delayed (144 h [36-312] versus 42 h (2-480]) with the ODF under fed versus fasting conditions (p = 0.0371). The point estimates and 90 % CIs of the Test_fed/Reference_fed ratios of the geometric means showed that the bioavailability of exogenous 25(OH)D3 was, both in rate and extent of absorption, slightly higher with the vitamin D3 ODF than the vitamin D3 oral solution under the administration conditions recommended for the vitamin D3 oral solution. Palatability and ease of use of the ODF were satisfactory.

CONCLUSION:

The new ODF 25000 I.U. formulation provided a valuable alternative to the marketed oral solution for therapeutic vitamin D supplementation, with a bioavailability that was slightly higher than that of the vitamin D3 oral solution administered under the same conditions.

TRIAL REGISTRATION:

The study was retrospectively registered with the ISRCTN Registry (Registry code: ISRCTN13208948) on 27 November 2020.

2020-06-22·BioMed research international3区 · 生物学

Safety Assessment of High- and Low-Molecular-Weight Hyaluronans (Profhilo®) as Derived from Worldwide Postmarketing Data

3区 · 生物学

ArticleOA

作者: Cassuto, Daniel ; Delledonne, Mara ; Illiano, Immacolata ; Giori, Andrea Maria ; Bellia, Gilberto ; Zaccaria, Giovanna

Background. At present, dermal fillers based on hyaluronic acid (HA) represent the most popular intervention of dermoesthetic medicine for the treatment of skin aging. Recent studies have shown that the combination of HA chains of different lengths and molecular weights improves tissue repair and regeneration through a synergistic mechanism. Profhilo® is a product available that has been on the market since 2015 and is based on stable, hybrid, and cooperative complexes (HyCoCos) produced by means of NAHYCO® Hybrid Technology, which is an innovative thermal process that rules out the use of any chemical reagents. The result is a filler with high biocompatibility and low viscosity that favors optimal diffusion at the tissue level to obtain the target bioremodeling of the facial contour. The objective of this review is to provide data from the overall postmarketing experience after 3 years of use and more than 40,000 patients treated with the medical device. Methods. All spontaneous postmarketing adverse event (AE) reports received from physicians and healthcare professionals worldwide between February 9, 2015, and February 8, 2018, associated with the use of the studied medical device and sent to the IBSA global safety database were analyzed. Results. In total, 12 adverse event reports were logged in the global database, and none were considered serious. Early-onset injection site reactions, i.e., swelling, edema, redness, ecchymosis, and erythema, were the most frequently observed. Late-onset local reactions (e.g., swelling, nodules) followed. The genesis of these reactions was considered, both by the reporting physician and IBSA, as being local reactions of hypersensitivity and/or due to inappropriate injection techniques. In no case was the product held liable for direct damage. All events resolved without any complications according to the treatment guidelines. Two late-onset reactions were collected. Conclusions. Although underreporting of minor events cannot be ruled out, the overall number of reports is very low, thereby supporting the high tolerability and safety of the product. After 3 years of postmarketing experience, the safety profile of the studied medical device is favorable and consistent with the product information.

项与 Ibsa Farmaceutici Italia Srl 相关的新闻（医药）

2023-01-03

·BioSpace

Yaral Pharma Launches Diclofenac Epolamine Topical System 1.3%

Authorized Generic of Flector® Now Available PARSIPPANY, N.J.--(BUSINESS WIRE)-- Yaral Pharma Inc., the US generics subsidiary of IBSA, a long-standing, multinational pharmaceutical company headquartered in Lugano, Switzerland today announced the launch of diclofenac epolamine topical system 1.3%, the authorized generic of IBSA Pharma’s Flector® (diclofenac epolamine) topical system. Diclofenac epolamine topical system 1.3% is a prescription nonsteroidal anti-inflammatory (NSAID) medicated patch indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. “We are excited to kick off the new year by launching the first of several products in our portfolio which includes authorized and complex generic medications,” said Stephen Beckman, CEO, Yaral Pharma. “Like Flector, Yaral Pharma’s diclofenac epolamine topical system 1.3% offers patients a non-opioid topical treatment backed by more than 30 years of clinical experience. We are pleased to offer patients an accessible and affordable product that offers targeted topical pain relief and look forward to expanding our product line across a range of therapeutic areas in the months ahead.” Yaral Pharma’s diclofenac epolamine topical system 1.3% patch (NDC 82347-0405-5) is currently available to order. For questions about ordering, contact Yaral Pharma at 1-866-218-9009. Yaral Pharma has begun commercializing IBSA Pharma’s authorized generics and is poised to rapidly expand its product line organically through outside opportunities and external partnerships with a focus on oral solid dosage (OSD), complex and 505(b)2 products. The Company’s current portfolio includes products in the therapeutic areas of pain and endocrinology with future expansion planned in the areas of rheumatology, fertility/women's health, dermatology/dermo-aesthetic, and ophthalmology. For the latest updates on Yaral Pharma, visit or connect with us on LinkedIn. Product Information Product Strength NDC # Package Size Diclofenac epolamine topical system 1.3% 82347-0405-5 One Carton = 30 patches To order, please call Yaral Pharma at 1-866-218-9009. Please refer to the full Prescribing Information, including Boxed Warning for diclofenac epolamine topical system, 1.3% here. You are encouraged to report suspected adverse reactions to Yaral Pharma by emailing MI@yaral-pharma.com or calling 866-218-9009 or to the FDA by visiting . WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. Diclofenac epolamine topical system 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. About Authorized Generics According to the U.S. Food and Drug Administration, the term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. The product the patient receives is identical to the branded product, contains the same active and inactive ingredients, and is manufactured using the same process at a considerable cost savings. About Yaral Pharma Yaral Pharma Inc. (Parsippany, NJ) is the US generics subsidiary of IBSA, a global pharmaceutical company headquartered in Switzerland. By focusing on people and innovating the ways they’re cared for, Yaral Pharma is proud to offer the same values and expertise of its parent company to the US market. Dedicated to ensuring access to affordable authorized generics (AGs) and complex generic medicines that enhance healthcare outcomes, Yaral Pharma offers its customers high-quality products across a range of therapeutic areas, continuity of supply, and a commitment to exceptional customer service. For more information, visit or contact info@yaral-pharma.com or 866-218-9009. Flector® is a registered trademark of IBSA Institut Biochimique S.A.

2022-12-12

·Business Wire

Yaral Pharma Launches in the US

PARSIPPANY, N.J.--( BUSINESS WIRE )-- Yaral Pharma Inc. , the US generics subsidiary of IBSA, a long-standing, multinational pharmaceutical company headquartered in Lugano, Switzerland, launched today with the mission of providing access to high quality, affordable, authorized generics (AG) and complex generic medicines to enhance healthcare outcomes. Led by a team of industry veterans, Yaral Pharma will begin commercializing the first product from IBSA’s corporate pipeline of authorized generics in January 2023. Yaral Pharma’s current portfolio includes products across a range of therapeutic areas, including pain and endocrinology. It plans to rapidly expand its product line and therapeutic areas of focus through outside opportunities and external partnerships. IBSA is particularly known for its manufacturing expertise and decades-long track record of product quality and supply continuity. The Company continues to build a wide-ranging portfolio of products across brands and generics in ten core therapeutic areas including pain and inflammation and endocrinology and manufactures novel delivery systems including soft gel capsules and patch technology. IBSA is also recognized as one of the largest players worldwide in the area of reproductive medicine and one of the world’s leaders in hyaluronic acid-based products. “ Our parent company IBSA is recognized as a world leader in the development of innovative technologies and products that improve the health and wellness of people,” said Stephen Beckman, CEO, Yaral Pharma. “ We look forward to drawing on these strengths and providing our customers with high-quality products, continuity of supply, and exceptional levels of service.” For the latest updates on Yaral Pharma, please visit www.yaral-pharma.com or connect with us on LinkedIn . About Authorized Generics According to the U.S. Food and Drug Administration, the term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. The product the patient receives is identical to the branded product, contains the same active and inactive ingredients, and is manufactured using the same process at a considerable cost savings. About Yaral Pharma Yaral Pharma Inc. (Parsippany, NJ) is the US generics subsidiary of IBSA, a global pharmaceutical company headquartered in Switzerland. By focusing on people and innovating the ways they’re cared for, Yaral Pharma is proud to offer the same values and expertise of its parent company to the US market. Dedicated to ensuring access to affordable authorized generics (AGs) and complex generic medicines that enhance healthcare outcomes, Yaral Pharma offers its customers high-quality products across a range of therapeutic areas, continuity of supply, and a commitment to exceptional customer service. For more information, visit www.yaral-pharma.com or contact info@yaral-pharma.com or 866-218-9009. About IBSA IBSA (Institut Biochimique SA ) is a Swiss multinational pharmaceutical Company, founded in 1945 in Lugano. Today, its products are present in over 90 Countries on 5 continents, through the Company’s 17 subsidiaries located in Europe, China, and the United States. The company has a consolidated turnover of 800 million CHF, and employs over 2,000 people between headquarters, subsidiaries and production sites. IBSA holds 90 families of approved patents, plus others under development, as well as a vast portfolio of products, covering 10 therapeutic areas: reproductive medicine, endocrinology, pain and inflammation, osteoarticular, aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic, respiratory, consumer health. It is also one of the largest operators worldwide in the area of reproductive medicine, and one of the world’s leaders in hyaluronic acid-based products. IBSA has based its philosophy on four pillars: Person, Innovation, Quality and Responsibility.

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