Overview

Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Disphar International B.V.
Treatments:
Gliclazide