Clinical trials: Therapeutic Equivalency, Healthy
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)
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
Healthy, Healthy Donors
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition
- Trial name
- NCT06861842
- Testing
- Theralite®, Actilitio®
- Where
- Colombia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
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
Healthy Subjects
Bioequivalence Study of Aripiprazole in Healthy Adult Subjects Under Fasting Condition
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Aripiprazole 10 mg, after administering a single oral dose, to healthy adult…
- Trial name
- NCT05532254
- Testing
- Aripiprazole 10 mg tablet, Abilify® 10 mg tablet
- Where
- Egypt
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Future University in Egypt
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
Irbesartan Tablets (0.15g/Tablet), Under Fasted Condition
A Bioequivalence Trial of Irbesartan Tablets（0.15g） in Healthy Chinese Subjects
To study the pharmacokinetics of test preparation and reference preparation irbesartan tablets (0.15g/tablet) in a single oral administration in fasting and fed state,respectively, in healthy adult subjects, and to evaluate the…
- Conditions
- Irbesartan Tablets (0.15g/Tablet), Under Fasted Condition, Under Fed Condition, Bioequivalence
- Trial name
- NCT05297929
- Testing
- Irbesartan Tablet
- Where
- China
- Volunteers
- 54 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under…
- Trial name
- NCT00835705
- Testing
- amoxicillin-clavulanic acid, Augmentin®
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Anti-Infective Agents
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods.
- Trial name
- NCT01073553
- Testing
- Cephalexin capsules (Optocef, BAYO5448 ), Cephalexin capsules (Keflex)
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants.
- Trial name
- NCT04314037
- Testing
- Cesol (Test), Biltricide (Reference)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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