Clinical trials: Therapeutic Equivalency
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.
To Determine Bioequivalence Under Fed Conditions
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
- Trial name
- NCT00652730
- Testing
- Buspirone HCl, Buspar
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.
- Trial name
- NCT00648219
- Testing
- Olmesartan Medoxomil Tablets 40 mg, Benicar® Tablets 40 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI]…
- Trial name
- NCT02823171
- Testing
- Treatment A: 400 mg Pacritinib P3CT, Treatment B: 400 mg of pacritinib FMI
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference)…
- Trial name
- NCT05644353
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID: 855509)
The purpose of this study is to determine whether two different analgesic transdermal patch formulations lead to same plasma levels of active ingredient after multiple dose application.
- Trial name
- NCT00469053
- Testing
- Buprenorphine
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Healthy Adult Subjects
Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects
The primary objective of the study is to evaluate the bioequivalence of two different specification of reference preparation capsules (10 mg/capsule, 40 mg/capsule and 100 mg/capsule, 1 capsule each) and test preparations…
- Trial name
- NCT04521192
- Testing
- Fluzoparib
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.
- Trial name
- NCT00882700
- Testing
- Cefdinir 300 mg Capsule (Sandoz, Austria), Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sandoz
Seasonal Allergic Rhinitis
Clinical Equivalence Study of Mometasone Nasal Spray, 50 Mcg/Actuation
The objective of this study is to evaluate the clinical equivalence of the test formulation of mometasone furoate anhydrous 50 mcg/actuation nasal spray (manufactured by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT01523236
- Testing
- Mometasone furoate, Nasonex®
- Volunteers
- 800 people
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.
- Trial name
- NCT01151345
- Testing
- TILACEM, ANGIOTROFIN
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
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