Clinical trials: Bioequivalence Study
Heartburn
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation.
- Trial name
- NCT00945750
- Testing
- Famotidine FCT, Famotidine CT
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd.
- Trial name
- NCT00835640
- Testing
- Fexofenadine 180 mg tablets, ALLEGRA® 180 mg tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fed Bioequivalence Study of Fenofibric Acid Versus TriCor® (Fenofibrate)
This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition.
- Trial name
- NCT00960687
- Testing
- Fenofibric Acid (Fibricor™) 105 mg Tablet, Fenofibrate (Tricor®) 145 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the…
- Trial name
- NCT02246920
- Testing
- Fluticasone propionate, Flonase®
- Where
- United States
- Volunteers
- 1,474 people
- Sponsor
- Teva Pharmaceuticals USA
Major Depressive Disorder
Clinical Study of Generic and Brand Bupropion in Depression
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.
- Trial name
- BALANCE (NCT02209597)
- Testing
- Bupropion XL 300
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Washington University School of Medicine
Healthy
A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a…
- Trial name
- NCT02821338
- Testing
- Lamotrigine Extended Release
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Healthy
Granisetron 1 mg Tablets Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects…
- Trial name
- NCT00834717
- Testing
- Granisetron hydrochloride 1 mg tablets, Kytril® 1 mg tablets
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Therapeutic Equivalency
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or…
- Trial name
- NCT01436526
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bayer
Diabetes Mellitus
A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin.
- Trial name
- NCT01476345
- Testing
- LY2963016, Lantus
- Where
- South Africa
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00833937
- Testing
- Zolpidem 10 mg tablets, AMBIEN® 10 mg tablets
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation…
- Trial name
- NCT00830219
- Testing
- Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00684723
- Testing
- Lovastatin 40 mg Tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25 milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
- Trial name
- NCT02372097
- Testing
- SYR-472
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
- Trial name
- NCT00849797
- Testing
- Oxcarbazepine, Trileptal®
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
- Trial name
- NCT01101191
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Ovarian Cancer, Breast Cancer
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
- Trial name
- NCT05258747
- Testing
- Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Sandoz
Healthy
Topiramate 25 mg Capsules Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of topiramate 25 mg capsules (test) versus Topamax® (reference) administered as 2 x 25 mg capsules under fasting conditions.
- Trial name
- NCT00905164
- Testing
- Topiramate Capsules, 25 mg, Topamax® Capsules, 25 mg
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company…
- Trial name
- NCT01247272
- Testing
- Fluoxetine Hydrochloride, PROZAC WEEKLY®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Acne Vulgaris
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
- Trial name
- NCT02616614
- Testing
- Onexton, Clindamycin/benzoyl peroxide gel
- Where
- 17 sites in United States
- Volunteers
- 862 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.