At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Open Label, Single Dose, 4 Treatment, 4 Period, Crossover Design (4 x 4) Trial to Evaluate the Bioequivalence and Secondarily Drug - Drug Interaction of Fixed Combination of Metformin Tablets 1000 mg/Gliclazide 30 mg MR, Compared With the Co-administration of Individual Tablets and Individual Administration of Each Single Tablet (Metformin 1000 mg XR and Gliclazide 30 mg MR) in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Metformin/Gliclazide Fixed Combination, Metformin, and 1 other intervention for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed Summary
This study investigated the bioequivalence and drug-drug interaction of Metformin/Gliclazide fixed combination tablet compared to co-administration of individual tablets of Metformin and Gliclazide.
Study Details
Timeline
Interventions
Participants received single oral dose of Metformin and Gliclazide fixed combination tablet in treatment period 1, 2, 3 or 4.
Participants received single oral dose of Metformin tablet in treatment period 1, 2, 3 or 4.
Participants received single oral dose of Gliclazide tablet in treatment period 1, 2, 3 or 4.