Clinical trials: Therapeutic Equivalency
Healthy
Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.
- Trial name
- NCT01012934
- Testing
- Alendronate Sodium Tablets, 70 mg, Fosamax Tablets, 70 mg
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Type1 Diabetes
Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus
Primary Objective: To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses Secondary Objective: To…
- Trial name
- NCT01838083
- Testing
- Insulin glargine new formulation HOE901
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Sanofi
Healthy
Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects
This study evaluated the bioequivalence and safety of the test formulation (Tenofovir Disoproxil Fumarate Tablets, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (Viread®, Gilead Sciences, Inc.) in healthy…
- Trial name
- NCT07558967
- Testing
- Test Tenofovir Disoproxil Fumarate Tablets, Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）
- Where
- China
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Bioavailability
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.
- Trial name
- NCT00803192
- Testing
- Famotidine Tablets, 40 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Perrigo Company
Healthy
Randomized Study to Compare the Bioequivalence of Two Fluticasone Propionate 0.05% Topical Creams
The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical Fluticasone Propionate 0.05% Cream in healthy, female subjects.
- Trial name
- NCT00803465
- Testing
- Fluticasone Propionate 0.05% Cream-Reference Product, Fluticasone Propionate 0.05% Cream-Test product
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Padagis LLC
Healthy
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®.
- Trial name
- NCT03803371
- Testing
- Ultracet Tablets, Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers
To establish the bioequivalence and adhesion properties of transdermal clonidine prepared with Oppanol® brands of polyisobutylene (PIB) vs.
- Trial name
- NCT02096744
- Testing
- Catapres-TTS-1, Intervention 1: Catapres-TTS-3, Intervention 2: Catapres-TTS-3
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Intermittent Claudication
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol Tablets in Healthy Volunteers
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of…
- Trial name
- NCT06167265
- Testing
- Cilostazol Tablet 100 mg, PMR Tablet 145 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Healthy Volunteers
A Study of Soticlestat Tablets in Healthy Adults
The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B).
- Trial name
- NCT05284760
- Testing
- Soticlestat
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Takeda
Osteoarthritis, Knee
A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee"
This randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of Mylan's diclofenac gel in the symptomatic treatment of…
- Trial name
- NCT03172780
- Testing
- Diclofenac sodium gel 1%, Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%
- Where
- 32 sites in India
- Volunteers
- 1,220 people
- Sponsor
- Mylan Pharmaceuticals Private Limited
Healthy
Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration
Levothyroxine-sodium Bioequivalence Trial With Oral Single Dose Administration
- Trial name
- NCT06547242
- Testing
- Levothyroxin
- Where
- Germany
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Healthy Volunteers
Bioequivalence Study Between YHP1906 Tab. 5 mg and YHR1902 Tab. 5 mg
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
- Trial name
- NCT04316065
- Testing
- YHP1906, YHR1902
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Dry Mouth
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fasted conditions
- Trial name
- NCT01903122
- Testing
- Cevimeline
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers
The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.
- Trial name
- NCT06360081
- Testing
- Zongertinib manufacturer 1, Zongertinib manufacturer 2
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fed Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411953
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Comparative Bioavailability
Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets
The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences…
- Trial name
- NCT02980757
- Testing
- Gliclazide 120 mg MR Tablets Formula A, Gliclazide 120 mg MR Tablets, Gliclazide 120 mg MR Tablets Formula B
- Where
- Jordan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Disphar International B.V.
Bioequivalence
The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions
This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of candesartan in the two formulations in healthy subjects.
- Trial name
- NCT04012307
- Testing
- Candesartan Cilexetil 32mg, Atacand® PROTECT
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivalence Study of Sodium Divalproate Tablets 500 mg
The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health…
- Trial name
- NCT03914534
- Testing
- Valproic Acid 500 MG, Valcote 500 mg
- Where
- Colombia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tecnoquimicas
Healthy
Fasting Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 mg
The objective of this study is to investigate the bioequivalence of Mylan metformin hydrochloride ER tablets to Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administration under fasting conditions.
- Trial name
- NCT00650312
- Testing
- Metformin Hydrochloride ER Tablets 500 mg, Glucophage® XR Tablets 500 mg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
- Trial name
- NCT02183571
- Testing
- Merck Glucophage® high dose, BMS Glucophage® high dose, Merck Glucophage® low dose
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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