Clinical trials: Bioequivalence Study
Healthy
Food Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fed conditions.
- Trial name
- NCT00648583
- Testing
- Ondansetron Tablets 24 mg, Zofran® Tablets 24 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT01149473
- Testing
- Losartan potassium/Hydrochlorothiazide
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Allergic Contact Dermatitis
Bioequivalence of Ethylenediamine Dihydrochloride Study
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
- Trial name
- NCT01798589
- Testing
- Ethylenediamine dihydrochloride allergen patch
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Allerderm
Healthy
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed…
- Trial name
- NCT00649480
- Testing
- BALSALAZIDE DISODIUM CAPSULES, 750 MG, COLAZAL® Capsules 750 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Rhinitis
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
This study will be an open-label, randomized 2-way cross-over study to evaluate bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese male subjects.
- Trial name
- NCT03555890
- Testing
- Levocetirizine IRT 5 mg, Levocetirizine ODT 5 mg
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pain
Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.
The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.
- Trial name
- NCT01173627
- Testing
- Test fentanyl citrate 400 mcg troche, Actiq 400 mcg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy Volunteers
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers
This study aimed to evaluate the pharmacokinetic characteristics of montelukast sodium oral thin films and the bioequivalence between oral thin films and chewable tablets in healthy chinese volunteers under fed condition.
- Trial name
- NCT05531994
- Testing
- Montelukast sodium oral thin films with water (T), Montelukast sodium chewable tablets with water (R)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.
- Trial name
- NCT01511731
- Testing
- Famotidine, Pepcid
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Pain
Bioequivalence Study for Mejoral 500 Product
This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.
- Trial name
- NCT02504775
- Testing
- Mejoral® 500 Tablets, Tylenol® Caplets
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
The primary purpose of this study is to demonstrate the bioequivalence (BE) of a single subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.
- Trial name
- NCT05533801
- Testing
- Lecanemab
- Where
- United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams
The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.
- Trial name
- NCT00803166
- Testing
- Halobetasol Propionate 0.05% Cream-Reference Product, Halobetasol Propionate 0.05% Cream-Test product 1, Halobetasol Propionate 0.05% Cream-Test Product 2
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Healthy
Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions
To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine…
- Trial name
- NCT00778037
- Testing
- Cyclobenzaprine hydrochloride 10 mg tablet
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Iron Deficiency Anemia
A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anemia under fasting condition.
- Trial name
- NCT07790562
- Testing
- Ferric Derisomaltose Injection, Ferric Derisomaltose Injection [MonoFer®]
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Healthy
A Study of Two Macitentan Formulations in Healthy Adult Participants
The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult…
- Trial name
- NCT05433675
- Testing
- Macitentan
- Where
- Belgium
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actelion
Healthy
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects.
- Trial name
- NCT06558045
- Testing
- Rivaroxaban 20 mg film-coated tablet, Xarelto 20 mg film-coated tablet
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT06025214
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to 1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr.
- Trial name
- NCT01136525
- Testing
- Valacyclovir Hydrochloride
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.
- Trial name
- NCT00878514
- Testing
- Alprazolam, Xanax
- Where
- Finland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
A Study of Mirikizumab in Healthy Participants
The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or…
- Trial name
- NCT04607733
- Testing
- Mirikizumab Prefilled Syringe, Mirikizumab Autoinjector
- Where
- 4 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company