At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Empagliflozin 2.5 mg +3 moredrug
Likely dose
Empagliflozin 2.5 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.
Bioequivalence of Empagliflozin/Metformin (12.5mg/500mg) Fixed Dose Combination Tablets Compared to Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open Label, Randomised, Single Dose, Two Period, Two Sequence Crossover Study)
In Brief
A Phase 1 clinical trial evaluating Empagliflozin 2.5 mg, Empagliflozin 10 mg, and 2 other interventions for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionFeb 2014
TodayJul 2026
First PostedJan 7, 2014
Enrollment StartJan 1, 2014
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.5 years ago
Interventions
Empagliflozin 2.5 mgdrug
Empagliflozin 2.5 mg tablet
Empagliflozin 10 mgdrug
Empagliflozin 10 mg tablet
Metformin 500 mgdrug
Metformin 500 mg tablet
Empagliflozin/Metformin FDCdrug
12.5 mg Empagliflozin / 500 mg Metformin