Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets…
- Trial name
- NCT01508195
- Testing
- Canagliflozin tablets, Metformin IR tablets, Canagliflozin/metformin IR FDC tablets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Bioequivalence Study
Study to Assess the Bioequivalence Between D961S and Esomeprazole/Buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
The purpose of this study is to assess bioequivalence between D961S and esomeprazole/buffered ASA, safety, tolerability of esomeprazole in combination with ASA and pharmacokinetics (PK) of D961S, esomeprazole and buffered ASA…
- Trial name
- NCT01494402
- Testing
- D961S, Esomeprazole, Buffered acetylsalicylic acid
- Where
- Japan
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET in Healthy Subjects Under Fasting Conditions
To assess the bioequivalence of Test oral formulation of FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET versus Reference ANTADYS®100 mg Comprimé Pelliculé \& PEPCID® (Famotidine) 20mg Tablets, USP.
- Trial name
- NCT01910090
- Testing
- FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET, ANTADYS® 100 mg, PEPCID® 20 mg
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Research Unit, Jordan
Healthy
Bioequivalence Study of Lu AF35700
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
- Trial name
- NCT03394482
- Testing
- Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)
The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time.
- Trial name
- NCT06733688
- Testing
- Tedizolid Phosphate Oral Formulation 1 (Reference), Tedizolid Phosphate Oral Formulation 2 (Test)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Fed
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fed Conditions
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01884909
- Testing
- Metoprolol Succinate ER Tablet 200 mg, 'TOPROL-XL®' ER Tablets 200 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy Volunteer
Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers
- Trial name
- NCT06926387
- Testing
- YHP2407, YHR2502
- Where
- South Korea
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Drug Use
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT.
- Trial name
- NCT05753371
- Testing
- Metformin Hydrochloride 500 MG
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Pyridam Farma Tbk
Healthy
Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg
The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis' Lopressor® tablets following a single, oral 50 mg (2 x 25 mg tablets for Mylan's formulation and 1 x 50 mg for…
- Trial name
- NCT00648271
- Testing
- Metoprolol Tartrate Tablets 25 mg, Lopressor® Tablets 50 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Hypercholesterolemia
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
- Trial name
- NCT00917644
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
A Relative Bioavailability Study of Fentanyl 25 μg/h Transdermal System
To compare the rate and extent of absorption of fentanyl 25 μg/h transdermal system (test) and Duragesic (reference) administrated as 1 x 25 μg/h single transdermal system application.
- Trial name
- NCT00864565
- Testing
- Fentanyl 25 μg/h transdermal system, single application, Duragesic 25 μg/h transdermal system single application
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers
The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported…
- Trial name
- NCT01928316
- Testing
- Mizolastine domestic (made in China), Mizolastine (imported)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Parkinson Disease Psychosis
Bioequivalence Study of Pimavanserin 34 mg Capsule
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Pimavanserin 34 mg Capsule of Humanis Sağlık A.Ş., Turkey and NUPLAZID® (Pimavanserin) capsules…
- Trial name
- NCT06450184
- Testing
- Pimavanserin 34 mg, NUPLAZID 34 MG Oral Capsule
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence Study
Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets in Chinese Healthy Volunteers
The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.
- Trial name
- NCT05794919
- Testing
- Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g, Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Beijing Tongren Hospital
Healthy
Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fasting conditions.
- Trial name
- NCT00650364
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Major Depressive Disorder (MDD)
Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)]…
- Trial name
- NCT05417087
- Testing
- Vortioxetine Hemihydrobromide Orally Disintegrating Tablets, Vortioxetine Hydrobromide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seasons Biotechnology (Taizhou) Co., Ltd.
Healthy
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
- Trial name
- NCT02183571
- Testing
- Merck Glucophage® high dose, BMS Glucophage® high dose, Merck Glucophage® low dose
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Healthy
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fed…
- Trial name
- NCT00647751
- Testing
- Lamotrigine Tablets 25 mg, Lamictal® Tablets 25 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc