Clinical trials: Therapeutic Equivalency
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
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
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg)…
- Trial name
- NCT00649519
- Testing
- Amlodipine and Benazepril HCl Capsules 10 mg/20 mg, Lotrel® Capsules 10 mg/20 mg
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Overweight or Obesity
A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers
This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at steady state.
- Trial name
- NCT06013163
- Testing
- Xenical® vs EMP 22, EMP 22 vs Xenical®, EMP 16 vs Xenical®
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Empros Pharma AB
Type 2 Diabetes Mellitus
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
- Trial name
- NCT01068730
- Testing
- metformin (Diabex), metformin (Glucophage™)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Arterial Hypertension (PAH)
Bioequivalence Study to Compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) Versus Uptravi® 400mcg Film Coated Tablets (400 mcg Selexipag)
Randomized, single oral dose, two-period, two-treatment, two-sequence open-label, crossover, bioequivalence study to compare Selexipag 400mcg Film Coated Tablets (400 mcg Selexipag) versus Uptravi® 400mcg Film Coated Tablets (400…
- Trial name
- NCT06932198
- Testing
- Selexipag Film Coated Tablets, Uptravi® Film Coated Tablets
- Where
- Jordan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
- Trial name
- NCT04325009
- Testing
- Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab, Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Bioequivalence
Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions
This is an open-labeled, randomized, four period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Plavix®, 75 mg film-coated tablets) or the test…
- Trial name
- NCT05934799
- Testing
- Clopidogrel film-coated tablet 75 mg, Plavix® film-coated tablet 75 mg
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
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
Fasting
Bioequivalence Study of Olanzapine Tablets, 5 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fasting conditions and to monitor the…
- Trial name
- NCT01503398
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes Mellitus (T2DM)
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended-Release Tablets Versus Trijardy® XR Extended Release Film Coated Tablets
Randomized, Single Oral Dose, Two-period, Two Sequence, Open-label, Crossover, Bioequivalence Study to Compare Empagliflozin-Linagliptin-Metformin XR Tablet 25mg/ 5mg/1000mg (25mg Empagliflozin /5mg Linagliptin /1000mgMetformin…
- Trial name
- NCT07213895
- Testing
- Empagliflozin/Linagliptin/Metformin HCL, Trijardy® XR Extended release film coated tablets
- Where
- Jordan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence of Alprazolam Sublingual vs Oral Tablets
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.
- Trial name
- NCT00860119
- Testing
- alprazolam sublingual tablet, alprazolam oral tablet
- Where
- India
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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