At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Empagliflozin +5 moredrug
Likely dose
Not stated in 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 (850 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
In Brief
A Phase 1 clinical trial evaluating Empagliflozin, Empagliflozin + Metformin, and 1 other intervention for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedAug 27, 2012
Enrollment StartAug 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.8 years ago
Interventions
Empagliflozindrug
empagliflozin tablets and metformin tablet
Empagliflozin + Metformindrug
fixed dose combination tablet (low)
Metformindrug
empagliflozin tablets and metformin tablet
Metformindrug
empagliflozin tablet and metformin tablet
Empagliflozin + Metformindrug
fixed dose combination tablet (low)
Empagliflozindrug
empagliflozin tablet and metformin tablet