Clinical trials: Bioequivalence
Healthy Participants
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
- Trial name
- NCT05048784
- Testing
- Sotorasib
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Amgen
Chronic Heart Failure
Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B.…
- Trial name
- NCT06922253
- Testing
- Sacubitril and Valsartan-Test product, Sacubitril and Valsartan-Reference product
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Hypertension
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - B
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT02811731
- Testing
- CKD-330 16/5mg - B, Candesartan 16mg and Amlodipine 5mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Bioequivalence
A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT03975166
- Testing
- Test Product, Reference Product
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Bioequivalence
Pharmacokinetics of Metronidazole Dermal Products
Generate human PK data by collecting data following the application of metronidazole formulations.
- Trial name
- NCT03271983
- Testing
- Metronidazole gel 1, Metronidazole gel 2, Metronidazole cream
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Bioequivalence
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
ioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04546256
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditions.
- Trial name
- NCT01131702
- Testing
- Ranitidine
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Deflox Tablets Bioequivalence (BE) Trial
The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg) tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting conditions to healthy participants.
- Trial name
- NCT04132583
- Testing
- Deflox®, Cataflam DD®
- Where
- Mexico
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fasting…
- Trial name
- NCT00648531
- Testing
- Balsalazide Disodium Capsules 750 mg, Colazal® Capsules 750 mg
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers
An open, randomized, single-dose, three-cycle, three-sequence crossover study was conducted in 36 healthy volunteers under fasting condition to evaluate the bioequivalence of two abiratone acetate tablets.
- Trial name
- NCT04863105
- Testing
- Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single…
- Trial name
- NCT00974441
- Testing
- Divalproex Sodium, Depakote®
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Symptomatic Neurogenic Orthostatic Hypotension
Study of the Fed-Fast Pharmocokinetics and Bioequivalance of 300mg Capsules of Droxidopa
One purpose of this study is to determine if taking droxidopa after eating will have an effect on how the body processes (absorbs and eliminates) the drug in healthy elderly subjects.
- Trial name
- NCT01149629
- Testing
- Droxidopa
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chelsea Therapeutics
Healthy
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
- Trial name
- NCT01672788
- Testing
- Empagliflozin, Empagliflozin + Metformin, Metformin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study on fenofibrate formulations comparing fenofibrate 160 mg tablets of Ranbaxy…
- Trial name
- NCT00775827
- Testing
- fenofibrate 160 mg tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Therapeutic Equivalency
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
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
- NCT00684762
- Testing
- Cilostazol 100 mg Tablets, Cilostazol (Pletal®) 100 mg Tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Generic Drug Quality, Generic Formulation Interchangeability
Generic Formulations of Commonly-used Oral Drugs in Saudi Arabia:Interchangeability & Post-marketing Quality
Generic formulations of prescription drugs can, through their relatively lower cost, improve healthcare as long as they maintain their registration-quality and public trust.
- Trial name
- NCT01344070
- Testing
- one of the 15 drugs listed below
- Where
- Saudi Arabia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- King Faisal Specialist Hospital & Research Center
Healthy
Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed Conditions
The purpose of this bioequivalence study is to compare the test of Rivastigmine 1.5 mg Capsules of Dr.Reddy's Laboratories Limited with reference to Exelon 1.5 mg of Novartis in Healthy Subjects Under Fed Conditions.
- Trial name
- NCT01146041
- Testing
- Rivastigmine
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Mild Asthma
Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd
This is a pharmacodynamic bioequivalence bronchoprovocation study using single-dose, double-blind, double-dummy, randomized, study consisting of four study treatments (zero dose [Placebo], E.Q.
- Trial name
- NCT06618105
- Testing
- Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
- Where
- India
- Volunteers
- 144 people
- Sponsor
- Macleods Pharmaceuticals Ltd
Healthy Volunteers, Fasting Conditions
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
Bioequivalence study for the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg under fasting conditions in healthy volunteers
- Trial name
- NCT07399470
- Testing
- Test drug: Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg, Reference drug: Gemigliptin (Zemiglo) 50mg, Dapagliflozin/metformin (Xigduo XR) 10/1000 mg
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- LG Chem
HIV-1
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals
- Trial name
- NCT02202005
- Testing
- Nevirapine, Viramune®
- Where
- United Kingdom
- Volunteers
- 46 people
- Sponsor
- Ratiopharm GmbH