Clinical trials: Bioequivalence Study in Healthy Subjects
Bioequivalence in Healthy Subjects
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects
The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).
- Trial name
- NCT01399255
- Testing
- Insulin lispro
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
A Study of Mirikizumab in Healthy Participants
The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or…
- Trial name
- NCT04607733
- Testing
- Mirikizumab Prefilled Syringe, Mirikizumab Autoinjector
- Where
- 4 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01420458
- Testing
- Experimental
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Bioequivalency, Safety Issues
Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these…
- Trial name
- NCT06622148
- Testing
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer), Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Healthy
Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in…
- Trial name
- NCT01055938
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions
This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the comparative bioavailability of fluconazole in the two formulations in healthy…
- Trial name
- NCT04038008
- Testing
- Fluconazole, Diflucan®
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Male Subjects
Bioequivalence Study of CJ-30060 in Healthy Male Volunteers
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 10/160mg, Crestor® 20mg in healthy male volunteers.
- Trial name
- NCT03639493
- Testing
- Exforge® tab 10/160mg, Crestor® tab 20mg, CJ-30060 10/160/20mg
- Where
- South Korea
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the content of 1 x 150 mg extended-release capsule…
- Trial name
- NCT01282814
- Testing
- Venlafaxine Hydrochloride, Effexor® XR
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.
- Trial name
- NCT01004614
- Testing
- Amlodipine
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT06025214
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg…
- Trial name
- NCT04186936
- Testing
- Combination Caplet with Loperamide HCl and Simethicone, Loperamide HCl, Simethicone
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Healthy
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions
The purpose of this study is To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed…
- Trial name
- NCT01164787
- Testing
- Trandolapril, Mavik
- Where
- India
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers, Bioequivalence
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and…
- Trial name
- NCT01331993
- Testing
- VIMOVO (AstraZeneca), VIMOVO (Patheon), Marketed enteric-coated naproxen formulation
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Test of "Dong-a Bepotastine Besilate Tab" and "Twolion Tab"
An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab"…
- Trial name
- NCT03932435
- Testing
- Fisrt period TWLO_C, Fisrt period TWLO, Washout period
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions
The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate formulations after administration of single doses to normal healthy subjects under fed conditions.
- Trial name
- NCT00775918
- Testing
- Doxycycline monohydrate 100mg tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets
The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg…
- Trial name
- NCT01179646
- Testing
- Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Kremers Urban Development Company
Healthy
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of…
- Trial name
- NCT00415740
- Testing
- ELC200 (carbidopa+levodopa+entacapone)
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis
Bioequivalence
Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions
This study is designed in accordance with the European Medicines Agency (EMA) regulatory guidelines, with the aim of characterizing the bioavailability of febuxostat in the two formulations in healthy adult subjects.
- Trial name
- NCT03918551
- Testing
- Febuxostat, Adenuric
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fasting Conditions
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
- Trial name
- NCT01665222
- Testing
- Morphine Sulfate
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Inc.
Healthy
Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01888731
- Testing
- Lamotrigine
- Where
- India
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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