Clinical trials: Therapeutic Equivalency
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233097
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions
The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting conditions.
- Trial name
- NCT00778778
- Testing
- cefprozil 500mg tablets
- Where
- Canada
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test…
- Trial name
- NCT04753489
- Testing
- Rivaroxaban film-coated tablet 10 mg, Xarelto® film-coated tablet 10 mg
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Semi-replicate Crossover Bioequivalence Study of Dirithromycin of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions
The purpose of this study is to assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence…
- Trial name
- NCT02237768
- Testing
- DIRITHROMYCIN 500 MG ENTERIC COATED TABLET, DYNABAC 250 MG ENTERIC COATED TABLET
- Where
- Jordan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Research Unit, Jordan
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.
- Trial name
- NCT05954338
- Testing
- DWC202307, DWJ1543, DWC202216
- Volunteers
- 52 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Actinic Keratosis (AK)
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in…
- Trial name
- NCT03727074
- Testing
- 5-FU Cream, Efudex®, Vehicle
- Where
- United States
- Volunteers
- 462 people
- Sponsor
- Sol-Gel Technologies, Ltd.
Solid Tumor
A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated.
- Trial name
- NCT04035473
- Testing
- HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
- Where
- 7 sites in Australia, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Athenex, Inc.
Depressive Disorder
PAXIL CR Bioequivalence Study
This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.
- Trial name
- NCT00749359
- Testing
- Paxil CR
- Where
- 2 sites in United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of…
- Trial name
- NCT00961480
- Testing
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500mg, Comparator: sitagliptin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Bioequivalence
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 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
- NCT04564456
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate
The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated…
- Trial name
- NCT02402283
- Testing
- Metronidazole benzoate oral granules, Flagyl 400 mg Tablets
- Where
- Jordan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
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.
Bioequivalence
Bioequivalence Study of Favir 200 mg Film Tablet Kocak Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- NCT04444986
- Testing
- FAVIR 200 MG FT, AVIGAN 200 mg FT
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Kocak Farma
Pain
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
- Trial name
- NCT02549469
- Testing
- Naproxen Sodium ER (BAY117031), 20% HPMC, Naproxen Sodium ER (BAY117031), 30% HPMC, Naproxen Sodium ER (BAY117031), 40% HPMC
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Atenolol 100mg Tablets Under Fasting Conditions
The purpose of this study was to determine the bioequivalence of atenolol formulations after administration of single doses to normal healthy subjects under fasted conditions.
- Trial name
- NCT00775580
- Testing
- Atenolol 100mg Tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations
Generic describes a pharmaceutical product that does not have a brand name or trademark. Generic medications should be the equivalent of brand medications. Only their price should be different.
- Trial name
- NCT01400165
- Testing
- Trazodone, Quetiapine, Pindolol
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Ottawa
Healthy
Bioequivalence Study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
This is a bioequivalence study of Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited under fasting conditions.
- Trial name
- NCT01149967
- Testing
- Citalopram Hydrobromide
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
- Trial name
- NCT00864500
- Testing
- Clobetasol Propionate 0.05% lotion, single exposure, Clobex TM 0.05% Lotion, single exposure
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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
Bioequivalence
Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions
A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg…
- Trial name
- Bioequivalence (NCT04689919)
- Testing
- Rivaroxaban 20 MG Oral Tablet
- Where
- Pakistan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Karachi
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