跳至主要内容
临床试验/2023-509484-24-00
2023-509484-24-00已完成4 期

A pivotal, randomized, open-label, two-treatment, two-sequence, four periods, crossover clinical trial to evaluate the bioequivalence of single doses of Test product Sacubitril/Valsartan, film-coated tablets 97 mg/103 mg (Manufacturer: JSC «Farmak», Ukraine) and Reference Entresto®, film-coated tablets 97 mg/103 mg (Novartis Europharm Limited, Ireland) in healthy subjects under fasted conditions

Farmak JSC1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年5月6日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
36
试验地点
1

研究概览

简要总结

暂无简介。

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
Farmak JSC
申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

Olena Barbukho

Scientific

Farmak JSC

研究点 (1)

Loading locations...

相似试验

招募中
4 期
Open-label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, study to assess the bioequivalence between the test product Betahistine dihydrochloride 24 mg tablets from Esperante Development BV and reference product Betaserc® 24 mg tablets.
2025-522971-27-00Esperante Development B.V.24
招募中
1 期
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 80 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects under fasting condition.Prostate cancer
2024-518209-16-00Sun Pharmaceutical Industries Limited40
已完成
4 期
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fed condition.Atopic dermatitisPsoriatic arthritisUlcerative colitisRheumatoid arthritis
2024-512771-12-00Sun Pharmaceutical Industries Limited32
已完成
4 期
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Brivaracetam Tablets Ph. Eur. 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Briviact (brivaracetam) 100 mg film-coated tablets, Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium; Manufactured by UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium, in healthy adult, human subjects under fasting condition.Epilepsy
2024-516500-42-00Sun Pharmaceutical Industries Limited36
已完成
4 期
Randomized, Open-label, Single-Dose, Two-treatment, Two-period, Cross-over, Pivotal Bioequivalence Study Comparing Amoxicilin/Clavulanic acid powder for oral suspension 600 mg/42.9 mg/5 mL to Augemntin ES 600 mg/42.9 mg/5 mL powder for oral suspension in Healthy Adult Male and Female Volunteers under Fed Conditions.
2023-503233-22-00Tarchominskie Zaklady Farmaceutyczne Polfa S.A.56