Clinical trials: Therapeutic Equivalency
Fasting
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fasting conditions.
- Trial name
- NCT01286688
- Testing
- Terbinafine Hydrochloride Tablets, 250 mg
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Subjects
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
- Trial name
- NCT02965261
- Testing
- Torrent's Fluoxetine Tablets, Warner Chilcott LLC Sarafem Tablets
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Hypertension, Essential
Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it…
- Trial name
- NCT01227603
- Testing
- Nifedipine-candesartan FDC (BAY 98-7106), Nifedipine GITS (Adalat LA, BAYA1040), Candesartan (Atacand)
- Where
- Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)
This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts.
- Trial name
- NCT06942741
- Testing
- Calderasib OCT, Calderasib FCT
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions.
- Trial name
- NCT00847405
- Testing
- Sumatriptan Succinate, Imitrex®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Leflunomide 20 mg Tablets, Non-Fasting
The objective of this study is to compare the relative bioavailability of leflunomide 20 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00834405
- Testing
- ARAVA® 20 mg tablets, Leflunomide 20 mg Tablets
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions
The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.
- Trial name
- NCT02941731
- Testing
- HIP1403, HGP0919
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
To Determine Bioequivalence Under Fed Conditions
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05329857
- Testing
- Metformin and Vildagliptin 1000/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Healthy, Obesity
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product [formulation A]) and in a vial (test product [formulation B2]) in male and female trial participants…
- Trial name
- NCT07768813
- Testing
- Survodutide formulation A, Survodutide formulation B2
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Amoxicillin 400 mg/Clavulanic Acid 57 mg Chewable Tablets Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg clavulnic acid (as the potassium salt) chewable…
- Trial name
- NCT00778661
- Testing
- amoxicillin 400mg + clovalunic acid 57.5mg tablets
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men…
- Trial name
- NCT03456960
- Testing
- TAK-438ASA, TAK-438, Aspirin
- Where
- Japan
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Takeda
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)
Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fed conditions.
- Trial name
- NCT01570894
- Testing
- Quetiapine Fumarate
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bioequivalence
Bioavailability of Levodopa 250 mg and Carbidopa 25 mg With Regards to Reference Product
This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 tablet formulation containing Levodopa 250 mg and Carbidopa 25 mg.
- Trial name
- NCT05250141
- Testing
- Levodopa 250mg and Carbidopa 25mg Test Drug tablet, Levodopa 250mg and Carbidopa 25mg Referent Product tablet
- Where
- India
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Healthy
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.
- Trial name
- NCT01511731
- Testing
- Famotidine, Pepcid
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Psoriasis, Rheumatoid Arthritis
BE Study in Patients - Methotrexate Tablets
To characterize the pharmacokinetic profile of the Test product - Methotrexate Tablets USP, 2.5 mg of Amneal Pharmaceuticals, compared to that of the corresponding Reference product - Methotrexate Tablets USP 2.5 mg manufactured…
- Trial name
- NCT02940561
- Testing
- Methotrexate - Amneal, Methotrexate - DAVA
- Where
- 3 sites in India
- Volunteers
- 48 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Healthy Volunteers
A Study of Evacetrapib in Healthy Japanese Participants
The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body.
- Trial name
- NCT02226653
- Testing
- Evacetrapib
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Cataract
Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension
A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd.
- Trial name
- NCT03499873
- Testing
- Nepafenac 0.3% Oph Susp, Nepafenac 0.3% Oph Susp (reference)
- Where
- United States
- Volunteers
- 448 people
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers
Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.
- Trial name
- NCT02221401
- Testing
- Linagliptin/Metformin FDC, Linagliptin, Metformin
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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