Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Bioequivalence of Bicalutamide New Formulation in Japan
The purpose of this study is to investigate the bioequivalence of Bicalutamide new formation with Casodex commercial tablet (80mg) in Japanese healthy male subjects
- Trial name
- NCT01416870
- Testing
- ICI176,334-1, Casodex 80 mg tablet
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fed Conditions
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study
- Trial name
- ACL25-PC007 (NCT07698288)
- Testing
- Tamsulosin 0.4 mg ER tablet
- Where
- Mexico
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.
- Trial name
- NCT00881894
- Testing
- Rotigotine transdermal patch
- Where
- Germany
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Pharmacokinetic Analysis, Bioequivalence
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
Pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, bioequivalence study of Levetiracetam 1500 mg coated granules in sachet formulations and Keppra (Levetiracetam) 2 x…
- Conditions
- Pharmacokinetic Analysis, Bioequivalence, Health Adult Subjects
- Trial name
- NCT07393022
- Testing
- Levetiracetam 1500 mg, Keppra® 750 mg
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Desitin Arzneimittel GmbH
Bioequivalence, Healthy Volunteers
A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms
This is a single-dose, randomized, two-period cross-over study with 72 healthy male and female volunteers. The investigational products will be given (after fasting overnight) at separate visits separated by 7 ± 3 days.
- Trial name
- NCT03213353
- Testing
- Tablet paracetamol, guaifenesin and phenylephrine HCL, Vicks Active SymptoMax Plus powder for oral solution
- Where
- Russia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Schizophrenia
A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville
The purpose of this study is to establish bioequivalence of paliperidone ER tablets manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville, administered as a single dose of 12 mg under fasted…
- Trial name
- NCT00790777
- Testing
- Paliperidone ER
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Rhinitis
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
This study will be an open-label, randomized 2-way cross-over study to evaluate bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese male subjects.
- Trial name
- NCT03555890
- Testing
- Levocetirizine IRT 5 mg, Levocetirizine ODT 5 mg
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
- Trial name
- NCT02965261
- Testing
- Torrent's Fluoxetine Tablets, Warner Chilcott LLC Sarafem Tablets
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Adult Subjects
A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers
The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects.
- Trial name
- NCT04400123
- Testing
- Famitinib malate
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Bioequivalence
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Trial name
- NCT06830954
- Testing
- Group A, Reference Group
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Bioequivalence
Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Toradiur®, 10 mg) or the test (Torasemide, 10…
- Trial name
- NCT04921566
- Testing
- Torasemide tablet 10 mg, Toradiur® tablet 10 mg
- Where
- Russia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Volunteers
Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080469
- Testing
- Tacrolimus 1 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Type 2 Diabetes
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab.
- Trial name
- NCT04317703
- Testing
- Gemigliptin tartrate sesquihydrate and metformin, gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release
- Where
- Thailand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition
The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions
- Trial name
- NCT01694797
- Testing
- Metoprolol Succinate
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Chronic Heart Failure
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
Primary objective is to is to evaluate the bioequivalence of two formulations
- Trial name
- NCT06266988
- Testing
- Sacubitril and Valsartan Tablets 97mg/103mg, Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Viatris Inc.
Healthy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
- Trial name
- NCT00946036
- Testing
- Sertraline Hydrochloride
- Where
- Canada
- Sponsor
- Torrent Pharmaceuticals Limited
Fasting
Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75 mg tablet under fasting condition.
- Trial name
- NCT01506713
- Testing
- Clopidogrel
- Where
- Canada
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
The objective of this study is to compare the rate and extent of absorption of nateglinide 120 mg tablet (test) versus Starlix ® (reference), administered as 1 x 120 mg tablet under fasting conditions.
- Trial name
- NCT01159158
- Testing
- Nateglinide
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
A Study of Cephalexin Capsules in Healthy Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin in capsules to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02123446
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Fasting 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…
- Trial name
- NCT00650208
- Testing
- Lamotrigine Tablets 25 mg, Lamictal® Tablets 25 mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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