Clinical trials: Bioequivalence Study
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc.
- Trial name
- NCT00939367
- Testing
- Zolpidem Tartrate Tablets 10 mg, 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Japanese Healthy Adult Male
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg…
- Trial name
- NCT03808493
- Testing
- TAK-438 OD, TAK-438
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Participants
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
- Trial name
- NCT05048784
- Testing
- Sotorasib
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Amgen
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
Healthy
Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT01046253
- Testing
- Lansoprazole, Prevacid®
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Helminthiasis
Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population
The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.
- Trial name
- NCT01755637
- Testing
- Albendazole
- Where
- 2 sites in China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Glimepiride 4 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00835172
- Testing
- Glimepiride 4 mg Tablets, AMARYL® 4 mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Famciclovir 500 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under non-fasting conditions.
- Trial name
- NCT00834444
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA…
- Trial name
- NCT00834587
- Testing
- 5 mg/500 mg METAGLIP™ Tablets, 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759902
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector compared to mirikizumab (reference) solution…
- Trial name
- NCT05515601
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hypertension
Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions
The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ) (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and hepatic cirrhosis with ascites and edema.
- Trial name
- NCT03031496
- Testing
- GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets), Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets)
- Where
- South Africa
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Colchicine Tablets
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with…
- Trial name
- NCT01021020
- Testing
- Colchicine, Colchicine/Probenecid
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411940
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Chronic Obstructive Pulmonary Disease
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
The study will assess the Pharmacokinetic (PK) and safety of BGF MDI [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane…
- Trial name
- NCT05477108
- Testing
- Treatment A (BGF MDI HFO with oral activated charcoal), Treatment B (BGF MDI HFA with oral activated charcoal)
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Adults
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and…
- Trial name
- NCT03168022
- Testing
- Treatment A, Treatment B
- Where
- Canada
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Healthy
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36…
- Trial name
- NCT00838630
- Testing
- Cilostazol 100 mg tablets, Pletal® 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a…
- Trial name
- NCT00830258
- Testing
- Pravastatin sodium 80 mg tablets, Pravachol® 80 mg tablets
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA