Clinical trials: Bioequivalence Study in Healthy Subjects
FED
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Non-Fasting Conditions
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under…
- Trial name
- NCT01283867
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg-42.9 mg/ 5 mL Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Ranbaxy Laboratories Limited, India, Amoxicillin-Clavulanic acid and GlaxoSmithKline, U.S.A.
- Trial name
- NCT00778544
- Testing
- amoxicillin-clavulanic acid 600 mg- 42.9 mg/ 5 mL oral suspension
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Adult Subjects
A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product
To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.
- Trial name
- NCT02444507
- Testing
- Nexium powder for injection and infusion 40 mg, Esomelone Powder for Solution for Injection / Infusion 40 mg
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- isRed Pharma & Biotech Research Corporation
Healthy
Azithromycin 600 Mg Tablets, Fed
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially…
- Trial name
- NCT00834132
- Testing
- Azithromycin 600 mg Tablet, Zithromax® 600 mg Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron orally disintegrating 8 mg tablets to GlaxoSmithKline's Zofran ODT® 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered…
- Trial name
- NCT00649363
- Testing
- Ondansetron Orally Disintegrating Tablets 8 mg, Zofran ODT® Tablets 8 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan
A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component…
- Trial name
- NCT02088008
- Testing
- cinidipine, valsartan
- Where
- South Korea
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Healthy
Glucophage Immediate Release (GIR) China Bioequivalence Study
The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
- Trial name
- NCT03393208
- Testing
- Test GIR, Reference GIR
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Volunteer
Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
- Trial name
- NCT06337409
- Testing
- Generic empagliflozin 25 mg film-coated tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- International Bio service
Dermatitis, Atopic
Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
Part A To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions To measure and…
- Trial name
- NCT04065633
- Testing
- P3-Fast, Comm-Fast, Vari-Fast
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions
This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.
- Trial name
- NCT01146106
- Testing
- Pravastatin Sodium
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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 Volunteers
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition
The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil…
- Trial name
- NCT01080443
- Testing
- Mycophenolate Mofetil Capsule 250 mg
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Healthy Volunteer, Dabigatran
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of…
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Trial name
- NCT06441916
- Testing
- Dabigatran Etexilate Capsules 150 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Bio service
Hepatocellular Carcinoma
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers
- Trial name
- NCT05068193
- Testing
- BR2008-1 (R), BR2008 (T)
- Where
- South Korea
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Healthy
Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fasting conditions.
- Trial name
- NCT00648921
- Testing
- Olanzapine Tablets 5 mg, Zyprexa® Tablets 5 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Ibuprofen 200 mg/5 mL Oral Suspension vs. MOMENT 200 mg Coated Tablet
The main objective of the study is to evaluate the bioequivalence of a new formulation of ibuprofen 200 mg/5 mL oral suspension vs.
- Trial name
- NCT02902289
- Testing
- Ibuprofen 200 mg/5 mL oral suspension, MOMENT 200 mg coated tablet
- Where
- Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Pharmacokinetics
Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.
This study was designed to assess the bioequivalence of Olanzapine tablets of two different manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two different manufacturers.
- Trial name
- NCT05123976
- Testing
- Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine), Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
- Where
- Czechia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy
Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam Extended-release 3 mg tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered…
- Trial name
- NCT00650299
- Testing
- Alprazolam Extended-release Tablets 3 mg, Xanax XR® Tablets 3 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod
The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No.
- Trial name
- NCT03757338
- Testing
- Fingolimod Reference Formulation, Fingolimod Test Formulation
- Where
- New Zealand
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Asofarma S.A.I. y C.
GERD
A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects
A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects
- Trial name
- NCT03211143
- Testing
- CKD-381, Nexium
- Where
- South Korea
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
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