Clinical trials: Bioequivalence Study
Healthy
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions
The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted…
- Trial name
- NCT00779233
- Testing
- Zidovudine tablets 300 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II
Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide (HCTZ) fixed dose combination compared with its monocomponents
- Trial name
- NCT02262858
- Testing
- Telmisartan and HCTZ, Telmisartan, HCTZ
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Fasting
Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions
To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid losartan metabolite \& Hydrochlorothiazide in…
- Trial name
- NCT01713647
- Testing
- Amlodipin, losartan, HCTZ
- Where
- Jordan
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Research Unit, Jordan
Healthy Adult Participants
A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets
The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.
- Trial name
- NCT03437564
- Testing
- Vortioxetine
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Takeda
Bioequivalence
A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314.
- Trial name
- NCT04527484
- Testing
- SHR-1314
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Asthma, Bioequivalence
A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
- Trial name
- NCT05021887
- Testing
- Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals, FLOVENT DISKUS
- Where
- Greece
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy Volunteers
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose…
- Trial name
- NCT06193187
- Testing
- Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg, Entresto 50 mg
- Where
- Thailand
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories (Thailand) Limited
Healthy
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.
- Trial name
- NCT01421043
- Testing
- triazolam liquid oral drops, triazolam tablets
- Where
- Belgium
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pfizer
Primary Hypercholesterolaemia
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
- Trial name
- NCT06884098
- Testing
- AD-228B, AD-2284
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Healthy
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fasting Conditions.
This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy…
- Trial name
- NCT01499758
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteer Male Subjects
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions
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
- NCT07156916
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of Wyeth consumer health care, USA, in normal…
- Trial name
- NCT01053208
- Testing
- Ibuprofen and Diphenhydramine Citrate
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bacterial Infections
Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.
The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400 mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl 125 mg/5 ml (125 mg Metronidazole Per 5 ml…
- Trial name
- NCT02146209
- Testing
- Metronidazole benzoate, Flagyl 125 mg/5 ml oral suspension, Flagyl 400 mg Tablets
- Where
- Jordan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
Hepatitis C
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule…
- Trial name
- NCT01181804
- Testing
- boceprevir
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg
The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg)…
- Trial name
- NCT00649233
- Testing
- Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg, Lopressor HCT® Tablets 100/50 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Overweight
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
- Trial name
- NCT01550926
- Testing
- 120 mg orlistat, 60 mg orlistat, orlistat experimental dose
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Learn How Different Forms of the Study Medicine Called Prazosin Are Taken up Into the Blood in Healthy Adults
Prazosin hydrochloride (HCl) is a medicine taken by mouth that helps lower high blood pressure. It's used to treat hypertension, as well as heart failure.
- Trial name
- NCT07231978
- Testing
- Prazosin HCl
- Where
- Belgium
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Pfizer
Asthma
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions
- Trial name
- NCT01659918
- Testing
- Montelukast, Singulair
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy Volunteers
Bioequivalence Study Comparing Two Tablet Formulations of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
A bioequivalence and food-effect study comparing two tablet formulations of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) in healthy adult subjects.
- Trial name
- NCT04421885
- Testing
- Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference, Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics
Healthy
Benazepril HCl 40 mg Tablets, Fasting
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the…
- Trial name
- NCT00836576
- Testing
- Benazepril HCl 40 mg Tablets, Lotensin® 40 mg Tablets
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA