Clinical trials: Therapeutic Equivalency
Diabetes
Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
- Trial name
- NCT00772265
- Testing
- Wosulin N, Novolin N
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Atrial Fibrillation (AF)
Bioequivalence Study of Dronedarone Hydrochloride Tablets
The test formulation of Dronedarone Hydrochloride Tablets (400 mg) is bioequivalent to the reference formulation (MULTAQ®) in healthy Chinese subjects under fed conditions.
- Trial name
- NCT07396519
- Testing
- Dronedarone Hydrochloride Tablets, MULTAQ® (Dronedarone Hydrochloride Tablets)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fed Condition
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® (Escitalopram…
- Trial name
- NCT01996475
- Testing
- Escitalopram Oxalate Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
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
Alendronate Sodium 70 mg Tablet Versus Fosamax® Under Fasting Conditions.
The objective of this study is to compare the rate and extent of absorption of alendronate sodium 70 mg tablets (test) versus Fosamax® 70 mg tablets (reference) administered as a single dose of 70 mg under fasting conditions.
- Trial name
- NCT00835406
- Testing
- Alendronate Sodium Tablets 70mg, Fosamax® Tablets 70mg
- Where
- Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers
This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in Chinese healthy volunteers.
- Trial name
- NCT00414947
- Testing
- Vildagliptin (LAF237)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novartis
Healthy
Bioequivalence Study of Anastrozole 1 mg Tablet
The purpose of this study is to characterize and compare the bioequivalence of CJ anastrozole [CJ Cheiljedang corp., Seoul, Korea] with Arimidex® [AstraZeneca, Wilmington, DE, USA].
- Trial name
- NCT01105299
- Testing
- CJ anastrozole 1 mg tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Asan Medical Center
Kidney Transplant Recipients, Liver Transplant Recipients
Pharmacokinetic Studies of Tacrolimus in Transplant Patients
The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney…
- Trial name
- PK (NCT01889758)
- Testing
- Prograf, Tacrolimus
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- University of Cincinnati
Bioavailability
A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions
The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability…
- Trial name
- NCT03905564
- Testing
- doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination, Diclegis (Registered Trademark)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Healthy
Bioequivalence Study of Losartan Potassium (100 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Cozaar® (100 mg Tablet) [Reference Formulation, Merck & Co. Inc., USA] in Healthy Human Volunteers Under Fed Condition
Objective: compare the single dose bioavailability of Torrent's Losartan Potassium Tablets 1 × 100 mg and Cozaar® Tablets 1 × 100 mg of Merck \& Co., Inc.
- Trial name
- NCT01218698
- Testing
- Losartan Potassium Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting…
- Trial name
- NCT00649636
- Testing
- Fluoxetine Capsules 40 mg, Prozac Pulvules 40 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
To Determine Bioequivalence Under Fasting Conditions
Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions
To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
- Trial name
- NCT00653055
- Testing
- Cabergoline, Dostinex
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
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
Healthy
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x…
- Trial name
- NCT01020214
- Testing
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg, Benicar HCT® Tablets 40 mg/25 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Histamine H1 Antagonists, Non-Sedating
To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup
To assess the bioequivalence of Loratadine Oral Solution/Syrup 1mg/mL (GPLA Formula) versus Claritin Peach Syrup 1mg/mL (ANNA Formula)
- Trial name
- Bordeaux (NCT02593747)
- Testing
- Loratadine oral solution, Loratadine (Claritin peach syrup)
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Participants
Riluzole Orodispersible Film Replicate Bioavailability
The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their…
- Trial name
- NCT04819438
- Testing
- Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets
- Where
- Switzerland
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Cross Research S.A.
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.
Bioequivalence, Asthma
Bioequivalence Study of Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT05085587
- Testing
- Test, Reference
- Where
- Greece
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Bioequivalence
Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace®, 10 mg tablets) or the test (Ramipril, 10 mg tablets)…
- Trial name
- NCT05438316
- Testing
- Ramipril tablet 10 mg, Tritace® tablet 10 mg
- Where
- Russia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Volunteer
A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after administration of tablet and capsule dosage forms…
- Trial name
- NCT02525484
- Testing
- Pirfenidone
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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