Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants
The purpose of this study is to evaluate the single-dose pharmacokinetic (PK) and bioequivalence of Darunavir (DRV) in the presence of Cobicistat (COBI) when administered as a DRV/COBI fixed dose combination (FDC) tablet…
- Trial name
- NCT05378906
- Testing
- DRV/COBI FDC, COBI, DRV
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Obesity&T2D
Bioequivalence Study of GZR18 Injection Before and After CMC Change
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
- Trial name
- NCT07355738
- Testing
- GZR18 injection A, GZR18 injection B
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions
The purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.
- Trial name
- NCT01645384
- Testing
- Atorvastatin Calcium Tablets, 40 mg
- Where
- India
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01506791
- Testing
- Desloratadine and pseudoephedrine
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Sleep Initiation and Maintenance Disorders
Bioequivalence and Food Effect Study in Healthy Volunteers
The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.
- Trial name
- NCT00495274
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- Italy
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Donepezil 10 mg Tablets Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of donepezil 10 mg tablet (test) versus Aricept® (reference), administered as 1 x 10 mg tablet under fed conditions.
- Trial name
- NCT01439243
- Testing
- Donepezil, Aricept®
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence
Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fed Conditions
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study
- Trial name
- ACL25-PC007 (NCT07698288)
- Testing
- Tamsulosin 0.4 mg ER tablet
- Where
- Mexico
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Fasting Study of Lorazepam Tablets 2 mg and Ativan Tablets 2 mg
The objective of this study was to investigate the bioequivalence of Mylan's lorazepam 2 mg tablets to Wyeth's Ativan 2 mg tablets following a single, oral 2 mg (1 x 2 mg) dose administered under fasting conditions.
- Trial name
- NCT00649818
- Testing
- Lorazepam Tablets 2 mg, Ativan Tablets 2 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.
- Trial name
- NCT00602589
- Testing
- Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Herpes Labialis
Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects
- Trial name
- NCT00711776
- Testing
- New formulation, Current formulation
- Where
- Japan
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type II
Bioequivalence Study for Acarbose / Metformin FDC
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
- Trial name
- NCT01728740
- Testing
- Acarbose/Metformin FDC (BAY81-9783), Acarbose (Glucobay, BAYG5421), Metformin
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233097
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
PAH
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fasting conditions.
- Trial name
- NCT06553924
- Testing
- Macitentan and Tadalafil film-coated tablets, PrOpsynvi® macitentan and tadalafil film-coated tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose
Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet
This was a single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to…
- Trial name
- NCT01677260
- Testing
- 500 mg metformin hydrochloride extended release caplet (test drug), 500 mg metformin hydrochloride prolonged release tablet (reference drug)
- Where
- Indonesia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Health
Bioequivalence Study Between UI009 and UIC202005 in Healthy Subjects
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Evaluate Bioequivalence After Dry-powder Inhalation of UIC202005 or UI009 in Healty Volunteers
- Trial name
- NCT07110740
- Testing
- UI009, UIC202005
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Healthy
ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants
The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the…
- Trial name
- NCT07652697
- Testing
- ABX-002
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Autobahn Therapeutics, Inc.
Healthy
Metformin ER 750 mg Tablets, Fed
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
- Trial name
- NCT00834613
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Embolism, Atrial Fibrillation and Venous Thrombosis
Bioequivalence Study of Rivaroxaban
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male…
- Trial name
- NCT02537457
- Testing
- Rivaroxaban (BAY 59-7939), Rivaroxaban (Xarelto, BAY 59-7939)
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bayer
Thrombocytopenia
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions.
- Trial name
- NCT06768619
- Testing
- Group 1: single-dose of test formulation+single-dose of reference formulation, Group 2: single-dose of reference formulation+single-dose of test formulation
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Bioequivalance
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fed Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL25-IC005 (NCT07763964)
- Testing
- Janumet XR, Sitagliptin/Metformin FDC
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
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