Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Volunteer
Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy…
- Trial name
- NCT07300033
- Testing
- Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL, Metformin Immediate-Release Tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Healthy Subjects
Bioequivalence Study Between YHP2508C and YHR2603 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508C and YHR2603 in healthy subjects
- Trial name
- NCT07584304
- Testing
- YHP2508C, YHR2603
- Where
- South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy Participants
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
- Trial name
- NCT05719805
- Testing
- Mavacamten
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080534
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
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
Bioavailability
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.
- Trial name
- NCT00802828
- Testing
- Famotidine Tablets, 40 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Perrigo Company
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Objective: Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test…
- Trial name
- NCT00939692
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
- Trial name
- NCT00864500
- Testing
- Clobetasol Propionate 0.05% lotion, single exposure, Clobex TM 0.05% Lotion, single exposure
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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.
Sever Aplastic Anaemia
A Bioequivalence Study of Hetrombopag in Healthy Subjects
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label…
- Trial name
- NCT05088655
- Testing
- Hetrombopag Olamine Tablet
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
- Trial name
- NCT00648440
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Infections, Bacterial
Amoxicillin Bioequivalence Study Brazil - Fast
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the…
- Trial name
- NCT01431989
- Testing
- Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL, Amoxil® 500mg/5mL powder for oral suspension
- Where
- Brazil
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of…
- Trial name
- NCT06331715
- Testing
- Palbociclib 125mg
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Megalabs
Healthy
Glucophage Immediate Release (GIR) China Bioequivalence Study
The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
- Trial name
- NCT03393208
- Testing
- Test GIR, Reference GIR
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Volunteers
A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects
This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects
- Trial name
- NCT02972125
- Testing
- Lacosamide (LCM) tablet, Lacosamide (LCM) dry syrup
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Healthy
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x…
- Trial name
- NCT01020214
- Testing
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg, Benicar HCT® Tablets 40 mg/25 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Risperidone 1 mg Tablets of Torrent Pharmaceuticals Limited, India and Risperdal® (Risperidone) 1 mg Tablets of Janssen Pharmaceutical Products, LP, USA, in Healthy Human Adult Subjects, Under Fed Conditions
Objective: To assess the bioequivalence of Risperidone 1.0 mg tablets of Torrent Pharmaceuticals Limited., India and Risperdal® (Risperidone) 1.0 mg tablets of Janssen Pharmaceutical Products, LP, USA, in healthy human adult…
- Trial name
- NCT00939926
- Testing
- Risperidone
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Subjects (HS)
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508B and YHR2602 in healthy subjects.
- Trial name
- NCT07912840
- Testing
- YHP2508B, YHR2602
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet…
- Trial name
- NCT01068743
- Testing
- saxagliptin, metformin, saxagliptin + metformin (FDC tablet)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 5 mg / 850 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC018 (NCT07633015)
- Testing
- Test. Empagliflozin/metformin 5/850 mg, Synjardy 5/850 mg tablet, Reference
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
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