Comparative Bioavailability Clinical Trial
Official title:
Comparative Randomized, Single Dose, Three-period Crossover Open-label Study to Determine the Bioequivalence of Gliclazide 120 mg Modified Release Tablets Formula A and Gliclazide 120 mg Modified Release Tablets Formula B Manufactured by Indeus Life Sciences PVT. Ltd., Relative to DIAMICRON MR® 60 mg 2 × of Les Laboratories Servier Industrie, France, After an Oral Administration of 120 mg to Healthy Adults Under Fasting Conditions
The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15 healthy adult subjects under fasting conditions. The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01960660 -
A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
|
N/A | |
| Completed |
NCT04790136 -
Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration
|
Phase 1 | |
| Completed |
NCT04505787 -
S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet
|
Phase 1 | |
| Withdrawn |
NCT02217670 -
Comparative Bioavailability Study of Metformin HCl 1000 mg Granules vs Glucophage 1000 mg Film-coated Tablet
|
Phase 1 |