View clinical trials related to Bioequivalence.
Filter by:This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Prestarium ® A 10 mg tablets) or the test (Perindopril 8 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
The experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. After a cleaning period, they entered the second cycle and received the control or test formulation in the same state. The cleaning period between the two cycles was 7 days.
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.
This is a Phase 1, open-label, multi-center, randomized, 2-period, adaptive design, crossover study to assess the bioequivalence of APL-101 (Vebreltinib) capsules and PLB-1001 (Bozitinib) capsules. The treatments to be administered orally in this study include: - Treatment A (reference): Two 100 mg APL-101 (Vebreltinib) capsules (200 mg dose), manufactured for Apollomics, Inc - Treatment P (test): Two 100 mg PLB-1001 (Bozitinib) capsules (200 mg dose), manufactured for Beijing Pearl Biotechnology Co., Ltd. APL-101 capsules (Treatment A) and PLB-1001 capsules (Treatment P) are similar drug products.
To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the bioequivalence of the two preparations
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan medoxomil/ hydrochlorothiazide in the two formulations (Olmesartan Medoxomil/ Hydrochlorothiazide (HCTZ), 40 mg/ 25 mg film-coated tablets (Manufacturer: Pharmtechnology LLC, Republic of Belarus) and Olmetec Plus® (Olmesartan Medoxomil/ Hydrochlorothiazide), 40 mg/25 mg film-coated tablets, (Manufacturer: Daiichi Sankyo Europe GmbH, Germany)) in healthy subjects. As this is a bioequivalence trial where each subject received each study treatment in a crossover fashion, a control group was not included. Within the clinical portion of the study each subject received a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints were the pharmacokinetic (PK) parameters Cmax and AUC0-t of olmesartan and hydrochlorothiazide.
To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10 mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects under fasting/fed condition as well as to monitor the safety and tolerability of subjects.