NCT02980757

Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Disphar International B.V. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Comparative Bioavailability

Interventions

Type	Name	Description
DRUG	Gliclazide 120 mg MR Tablets Formula A
DRUG	Gliclazide 120 mg MR Tablets
DRUG	Gliclazide 120 mg MR Tablets Formula B

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• First posted: 2016-12-02
• Last updated: 2016-12-02

Locations

1 site across 1 country: Jordan