Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Volunteer
Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects.
- Trial name
- NCT06388239
- Testing
- Apixaban 5MG
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy Subject
Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers
- Trial name
- NCT06920719
- Testing
- YHP2406, YHR2501
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy
Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x 15 mg) dose administration under fed…
- Trial name
- NCT00649675
- Testing
- Meloxicam Tablets 15 mg, Mobic® Tablets 15 mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Clonazepam ODT Under Fasting Conditions
To compare the single-dose bioavailability of Clonazepam ODT 1 mg and Klonopin Wafers 1 mg ODT
- Trial name
- NCT00652912
- Testing
- Clonazepam, Klonopin Wafers
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04400682)
- Testing
- FAVIRA 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novelfarma Ilaç San. ve Tic. Ltd. Sti.
Clinical Pharmacology
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects
To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U.
- Trial name
- NCT03517930
- Testing
- Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG), Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg…
- Trial name
- NCT04186936
- Testing
- Combination Caplet with Loperamide HCl and Simethicone, Loperamide HCl, Simethicone
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Healthy Participants
A Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen in Healthy Participants
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
- Trial name
- NCT03627936
- Testing
- Lorcaserin manufactured at Zofingen, Lorcaserin manufactured at Kawashima
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics and Safety of IN-M00007 and IN-R00007 in Healthy Adult Volunteers
This study aims to evaluate the Pharmacokinetic (PK) characteristics and safety after a single oral dose administration of IN-M00007 and IN-R00007 in healthy adult volunteers
- Trial name
- NCT07311811
- Testing
- IN-R00007, IN-M00007
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
Open-label, Bioequivalence Study of Certolizumab Pegol 200 mg Solution Injected Either by a Prefilled Syringe (Reference) or by an E-Device (Test) in Healthy Subjects
This is a single center, open-label, Phase 1 bioequivalence (BE) study in healthy subjects designed to demonstrate the bioequivalence of a single dose of certolizumab pegol (CZP) 200mg when injected by means of a prefilled…
- Trial name
- NCT02806219
- Testing
- Prefilled syringe (PFS), e-Device
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- UCB BIOSCIENCES, Inc.
Bioequivalence
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson\&Jonson", Russia)
- Trial name
- NCT04268472
- Testing
- GP30101, Prezista®
- Where
- Russia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female…
- Trial name
- NCT01020877
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Participants
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
- Trial name
- NCT05719805
- Testing
- Mavacamten
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Ivermectin Solution Bioequivalence Study - With Food
The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference…
- Trial name
- NCT00921674
- Testing
- ivermectin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Healthy
Bioequivalence Study of Metformin HCl 750 mg XR Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of metformin HC1 750 mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol Myers Squibb) in healthy, adult, subjects under…
- Trial name
- NCT00778791
- Testing
- metformin HC1 750 mg extended-release tablets
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fed
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503450
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
- Trial name
- NCT04816513
- Testing
- Ustekinumab
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Pharmacokinetic Study in Healthy Participants
Pharmacokinetic Study Comparing Blood Levels of Dasatinib in Healthy Participants Who Received the Tablet Formulation With Those Who Received Liquid and Tablet-dispersed Formulations
The purpose of the study is to compare the blood levels of dasatinib in healthy participants who received tablet formulation with those of healthy participants who received liquid and tablet-dispersed formulations of the drug.
- Trial name
- NCT01392703
- Testing
- Dasatinib as tablets, Dasatinib as liquid, Dasatinib as dispersed tablets
- Where
- United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.
- Trial name
- NCT00829894
- Testing
- Risperidone
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects
To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects
- Trial name
- NCT02426151
- Testing
- BEPO-A, REPO-A
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences