Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated…
- Trial name
- NCT02230046
- Testing
- Abiraterone acetate (Treatment A), Abiraterone acetate (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Participants
Bioequivalence Study of Rivaroxaban 2.5 mg Tablets Under Fasting and Fed Conditions
This completed study compared how the body absorbed a single 2.5 mg dose of a test rivaroxaban tablet and the reference product (Xarelto) in healthy adults.
- Trial name
- NCT07807488
- Testing
- Rivaroxaban 2.5 mg Test Tablet, Rivaroxaban 2.5 mg Reference Tablet
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
Metformin ER 750 mg Tablets, Fed
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
- Trial name
- NCT00834613
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Fed
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503450
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioequivalence Evaluation of a New and Current Tablet of ASP015K
The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
- Trial name
- NCT02531191
- Testing
- peficitinib
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Hypertension
Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT02186496
- Testing
- CKD-330 8/5mg, Candesartan 8mg and Amlodipine 5mg
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Pain
Bioequivalence of Single Dose Fast Release Aspirin (1000 mg) Tablet Versus Single Dose of Two 500 mg Fast Release Aspirin Tablets
The primary objective of this study is to compare the bioavailability of a single dose of a new 1000 mg fast release ASA (acetylsalicylic acid) tablet with that of two tablets of a commercially available 500 mg fast release…
- Trial name
- Mille (NCT03056703)
- Testing
- Acetylsalicylic acid (Aspirin, BAY1019036)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Phase1, Single Dose, Crossover Study to Determine Bioequivalence
The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).
- Trial name
- NCT00786240
- Testing
- Fesoterodine
- Where
- Singapore
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone…
- Trial name
- NCT00853190
- Testing
- Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule, 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Bioequivalence, AUC, Cmax, Pharmacokinetics
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co.
- Trial name
- NCT03121820
- Testing
- Memantinol tablets, 20 mg, Akatinol Memantine® tablets, 20 mg
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Geropharm
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Drug Use
Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects
The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT.
- Trial name
- NCT05468879
- Testing
- Glimepiride, Amaryl®
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- PT Harsen Laboratories
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
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
Food Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fed conditions.
- Trial name
- NCT00648154
- Testing
- Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered…
- Trial name
- NCT00647712
- Testing
- Divalproex Sodium Extended-Release Tablets 500 mg, Depakote ER® Tablets 500 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x 15 mg) dose administration under fed…
- Trial name
- NCT00649675
- Testing
- Meloxicam Tablets 15 mg, Mobic® Tablets 15 mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
Healthy
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
This is an single dose,two-way, crossover, oral bioequivalence study.
- Trial name
- NCT01513681
- Testing
- Lamotrigine, Lamictal®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Health Volunteer
A Bioequivalence Study of JS005 Pre-filled Syringe and JS005 Auto-injector
This study is a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects.
- Trial name
- NCT06732973
- Testing
- JS005
- Where
- China
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
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