Clinical trials: Therapeutic Equivalency
Asthma
Bioequivalence Study of Montelukast 5 mg Chewable
The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable…
- Trial name
- NCT01863654
- Testing
- Montelukast 5 mg chewable tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under…
- Trial name
- NCT00650234
- Testing
- Metformin Hydrochloride ER Tablets 500 mg, Glucophage® XR Tablets 500 mg
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671709
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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
Cataract
A Bioequivalence Study of Tobradex AF
The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
- Trial name
- NCT00362895
- Testing
- Tobramycin 0.3% / Dexamethasone 0.033% ophthalmic suspension, Tobramycin 0.3% / Dexamethasone 0.1% ophthalmic suspension (TOBRADEX)
- Where
- United States
- Volunteers
- 995 people
- Sponsor
- Alcon Research
Partial Onset Epilepsy
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.
- Trial name
- NCT01240187
- Testing
- perampanel
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)
This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg/2mL nebuliser suspension (IMP 08P1707F0) relaive to the reference product Pulmicort(r) 1.0mg/2mL suspension.
- Trial name
- BUNIPILOT (NCT06595121)
- Testing
- budesonide, Activated Charcoal
- Where
- Turkey (Türkiye)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Unither Pharmaceuticals, France
Chronic Myeloid Leukemia
Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body
1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG). 2.
- Trial name
- NCT01795716
- Testing
- mesylate imatinib capsule, Glivec
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fed conditions.
- Trial name
- NCT00972855
- Testing
- Bicalutamide, Casodex®
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Contraceptives, Postcoital
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods.
- Trial name
- LEVEQ-3 (NCT01073904)
- Testing
- Levonorgestrel Emergency Pill (BAY86-5028), Postinor 2
- Where
- Mexico
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects
This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male…
- Conditions
- Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy
- Trial name
- NCT01082406
- Testing
- catridecacog, recombinant factor XIII
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
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.
Healthy
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Fasting Conditions
To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest Pharmaceuticals, Inc., Lot No.
- Trial name
- NCT00864526
- Testing
- Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose, COMBONOX® tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Trial of a New Opioid Combination Compared to Reference
The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
- Trial name
- NCT00460785
- Testing
- Opioid
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fed Conditions
Objective: To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc.
- Trial name
- NCT01418443
- Testing
- Torrent's Pantoprazole Sodium Delayed - Release Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Amlodipine 10 mg Tablets Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fed conditions.
- Trial name
- NCT00841815
- Testing
- Amlodipine Besylate, Norvasc®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Relative Bioavailability Study of Gabapentin 800 mg Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis under fasting conditions.
- Trial name
- NCT00864760
- Testing
- Gabapentin 800 mg tablets, single dose (1 tablet), NEURONTIN® 400 mg capsules, single dose (2 capsules)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Solid Tumors
A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
This multi-center, open-label, pharmacokinetic study will evaluate the bioequivalence (BE) or relative bioavailability (rBA) of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral…
- Trial name
- NCT03362723
- Testing
- Idasanutlin
- Where
- 11 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Hoffmann-La Roche
Healthy
A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in subjects fed a standard meal.
- Trial name
- NCT00865462
- Testing
- Abrika Bupropion 150 mg XL Tablet, single dose, Wellbutrin XL® 150 mg Tablet, single dose
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Chronic Hepatitis B
Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers
After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.
- Trial name
- NCT02300688
- Testing
- Treatment A, Treatment B
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
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