Clinical trials: Bioequivalence
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
Haemophilia A
A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge
Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe…
- Trial name
- NCT05681845
- Testing
- NNC0365-3769 (Mim8)
- Where
- Germany
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Subjects
Bioequivalence of Dapagliflozin 10 mg Tablets Under Fed Conditions
The primary objective of this study is to evaluate the bioequivalence between: Dapagliflozin 10 mg tablets from Jiangsu Hansoh Pharmaceutical Group Co., Ltd.,China; and Farxiga® 10 mg tablets from AstraZeneca Pharmaceuticals LP…
- Trial name
- NCT04881006
- Testing
- Dapagliflozin 10 mg tablets, Farxiga® 10 mg tablets
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per…
- Trial name
- NCT04803734
- Testing
- Albuterol Sulfate inhalation aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy Adults
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period…
- Trial name
- NCT03898193
- Testing
- Montelukast, Singulair
- Where
- Russia
- Volunteers
- 34 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 Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in…
- Trial name
- NCT01344629
- Testing
- Telmisartan/Amlodipin FDC, Telmisartan, Amlodipin
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Diabetes, Healthy
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
- Trial name
- NCT01620437
- Testing
- biphasic insulin aspart 50
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (World Medicine, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04407000)
- Testing
- Test: Favipiravir 200 mg (LOQULAR), Reference: Favipiravir 200 mg (Avigan)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- World Medicine ILAC SAN. ve TIC. A.S.
Bioequivalence
Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product
This Pivotal study investigated the bioavailability in women of 2 tablet formulations containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30 subjects.
- Trial name
- NCT04422028
- Testing
- Desogestrel 0.075 MG
- Where
- Chile
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Healthy Volunteer
The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Acyclovir 800 mg Tablet and Reference Product (Zovirax™) in Healthy Thai Volunteers under Fasting Conditions
- Trial name
- NCT06228430
- Testing
- Acyclovir 800 mg Tablet, Zovirax™ 800 mg Tablet
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy Volunteers
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in…
- Trial name
- NCT01394224
- Testing
- Levetiracetam
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Pharmacokinetics
Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers
The objective of the study is to compare the bioavailability of the Test and Reference products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and female volunteers under fed conditions and to…
- Trial name
- NCT05124717
- Testing
- Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine), Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)
- Where
- Czechia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under…
- Trial name
- NCT01330303
- Testing
- Reference formulation, Test formulation
- Where
- Brazil
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence in Healthy Subjects
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects
The aim of this study is to assess the bioequivalence of two premixed formulations of insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic…
- Trial name
- NCT01400789
- Testing
- Insulin Lispro
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.
- Trial name
- NCT01179659
- Testing
- Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Kremers Urban Development Company
Healthy
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20…
- Trial name
- NCT00649597
- Testing
- Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Lotensin HCT® Tablets 20 mg/25 mg
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
- Trial name
- NCT02841150
- Testing
- IMBRUVICA (Treatment A), Ibrutinib (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hyperprolactinemia
A Study on Bioequivalence of Cabergoline Tablets in Human Body
The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.
- Trial name
- NCT07008417
- Testing
- Cabergoline tablets test formulation, Cabergoline tablets reference formulation
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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