Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
- Trial name
- NCT04325009
- Testing
- Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab, Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy Adult Males Volunteers
A Comparative Bioavalability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tabsulosine 0.4 mg Tablets in Healthy Adult Male Subjects, at Steady State
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg…
- Trial name
- NCT07146711
- Testing
- Tamsulosin (0.4 mg/j), Omnic Ocas®,
- Where
- Armenia
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.
- Trial name
- NCT00648219
- Testing
- Olmesartan Medoxomil Tablets 40 mg, Benicar® Tablets 40 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
A Pilot Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04462822
- Testing
- Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent, ADVAIR DISKUS® 250/50
- Where
- Greece
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Bioequivalence
The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions
This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of candesartan in the two formulations in healthy subjects.
- Trial name
- NCT04012307
- Testing
- Candesartan Cilexetil 32mg, Atacand® PROTECT
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions
To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in healthy, adult, human, male subjects under…
- Trial name
- NCT00775372
- Testing
- Clarithromycin 250mg/5mL
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080534
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Healthy
Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
- Trial name
- NCT01665209
- Testing
- Morphine Sulfate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Inc.
Respiratory Disorders, Asthma and Rhinitis
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator…
- Trial name
- NCT02658422
- Testing
- Test Montelukast, Reference Montelukast
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
This is an single dose,two-way, crossover, oral bioequivalence study.
- Trial name
- NCT01513681
- Testing
- Lamotrigine, Lamictal®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bio-equivalency Study of Moxifloxacin Tablets, 400 mg Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in human subjects under fasting conditions.
- Trial name
- NCT02322619
- Testing
- Moxifloxacin Tablets 400 mg
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fasting State
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting Condition
This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal…
- Trial name
- NCT01557439
- Testing
- Levocetirizine Dihydrochloride 5 mg Tablets
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy Volunteers, Fasting Conditions
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
- Trial name
- NCT07399470
- Testing
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially…
- Trial name
- NCT00834795
- Testing
- Carvedilol 25 mg tablets, COREG® 25 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
The purpose of this study is to demonstrate bioequivalence (BE) between Euthyrox® tablets manufactured at Merck Nantong (Test Euthyrox) versus the tablets manufactured at Merck Darmstadt (Reference Euthyrox).
- Trial name
- NCT05174000
- Testing
- Test Euthyrox®, Reference Euthyrox®
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.
Objective: A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine)…
- Trial name
- NCT00939614
- Testing
- Lamotrigine
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence, Phase 1
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy…
- Trial name
- NCT03273192
- Testing
- Adalimumab
- Where
- Iran
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Tablets 1g
The objective of this study was to confirm if two formulations of cephalexin tablets are bioequivalent. Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1 g Cephalexin; Eli Lilly).
- Trial name
- NCT01767584
- Testing
- Cephalexin 1g tablets
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 2
A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg taken without or with water and the Glucobay standard tablet 100 mg taken with water.
- Trial name
- NCT01554631
- Testing
- Acarbose (Glucobay ODT, BAYG5421), Acarbose (Glucobay, BAYG5421)
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting
The objective of this study is to compare the rate and extent of absorption of Glyburide/Metformin 5 mg/500 mg film-coated tablets (test) versus Glucovance® (reference) administered as 1 x 5 mg/500 mg film-coated tablet under…
- Trial name
- NCT00836472
- Testing
- Glyburide/Metformin 5 mg/500 mg Tablets, Glucovance® 5 mg/500 mg Tablets
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.