At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Metformin/Gliclazide Fixed Combinationdrug
Likely dose
Metformin/Gliclazide Fixed Combination 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, Single Dose, 2x2 Crossover Trial to Evaluate the Food Effect on the Bioavailability of a Metformin/Gliclazide Fixed Combination Tablet (1000 mg /30 mg MR) Given in Fasting and Fed Conditions to Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Metformin/Gliclazide Fixed Combination for Healthy. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose combination tablet in fed and fasted state.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesMexico
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartMar 2018
First PostedMar 2018
Primary CompletionApr 2018
TodayJul 2026
First PostedMar 16, 2018
Enrollment StartMar 6, 2018
Primary CompletionApr 22, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.3 years ago
Interventions
Metformin/Gliclazide Fixed Combinationdrug
Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.