Clinical trials: Therapeutic Equivalency
Type2diabetes
Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus…
- Trial name
- NCT06450262
- Testing
- Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets, Synjardy® 12.5mg/1000mg film-coated tablets
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Therapeutic Equivalency, Healthy
Fasted Bioavailability Study of Cilostazol Tablets, 50mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under…
- Trial name
- NCT00685802
- Testing
- Cilostazol 50 mg Tablets, Cilostazol (Pletal®) 50 mg Tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.
- Trial name
- NCT00658554
- Testing
- ARQ 197
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) 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 autoinjector compared to mirikizumab (reference) solution…
- Trial name
- NCT05515601
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Bioequivalence
A Pilot Bioequivalence Study of Pomalidomide
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Trial name
- NCT03424928
- Testing
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy
Ivermectin Solution Bioequivalence Study - With Food (Repeat)
The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin solution 1 mg/ml with a marketed reference…
- Trial name
- NCT00921219
- Testing
- ivermectin
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
- Trial name
- NCT02014272
- Testing
- RIN 150, reference drugs
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA)…
- Trial name
- NCT04573907
- Testing
- Drug Levothyroxine 100 mcg, Drug Eutirox 100 mcg
- Where
- Argentina
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Tecnoquimicas
Healthy
A Relative Bioavailability Study of Alprazolam 3 mg Extended Release Tablets Under Non-fasting Conditions
The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia \& Upjohn Company following a single oral dose (1 x 3…
- Trial name
- NCT00865657
- Testing
- Alprazolam 3 mg Extended Release Tablets, single dose, XANAX XR® 3 mg tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Cilostazol 50 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd.
- Trial name
- NCT00839930
- Testing
- Cilostazol 50 mg Tablets, Pletal®
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fasting…
- Trial name
- NCT00648466
- Testing
- Sumatriptan Succinate Tablets 100 mg, Imitrex® Tablets 100 mg
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Analysis of Crushed and Whole Tablet Genvoya
Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet.
- Trial name
- NCT03717129
- Testing
- Genvoya Oral dose, Genvoya Crushed Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
To Determine Bioequivalence Under Fed Conditions
A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study
The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
- Trial name
- NCT01380431
- Testing
- Lisinopril
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Lesinurad Tablet Bioequivalence
This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
- Trial name
- NCT02127775
- Testing
- Lesinurad 400 mg (manufactured at Site 1), Lesinurad 400 mg (manufactured at Site 2)
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Healthy
Bioequivalence Study of Tipranavir Stored at Controlled Temperature Compared With Tipranavir Stored at Controlled Refrigerated Conditions, Orally Co-administered With Ritonavir in Healthy Male and Female Volunteers
The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled temperature of 30°C and controlled relative…
- Trial name
- NCT02253888
- Testing
- TPV - Room condition, TPV - Refrigerated conditions, Ritonavir (RTV)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Postmenopausal Females
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2).
- Trial name
- NCT01345786
- Testing
- Commercial NOMAC-E2, Phase 3 NOMAC-E2 "Batch A", Phase 3 NOMAC-E2 "Batch B"
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healhty
Fed 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 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 10 mg/20 mg) dose…
- Trial name
- NCT00649402
- Testing
- Amlodipine and Benazepril HCl Capsules 10 mg/20 mg, Lotrel® Capsules 10 mg/20 mg
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
The purpose of this study is to evaluate the single-dose Pharmacokinetic (PK) and bioequivalence of darunavir (DRV) in the presence of cobicistat (COBI) when administered as a scored fixed dose combination (FDC) tablet (DRV/COBI)…
- Trial name
- NCT04718805
- Testing
- Darunavir, Cobicistat, Darunavir/Cobicistat FDC
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hypercholesterolaemia, Mixed Dyslipidaemia
Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Conditions
- Hypercholesterolaemia, Mixed Dyslipidaemia, Cardiovascular Diseases
- Trial name
- NCT06923956
- Testing
- Bempedoic Acid Film Coated Tablet, Nilemdo® (Bempedoic Acid) Film-coated tablets
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions
This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.
- Trial name
- NCT07260851
- Testing
- DWJ1622, DWC202313, DWC202314
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
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