At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
FDC 12.5mg empagliflozin/850mg metformin +2 moredrug
Likely dose
FDC 12.5mg empagliflozin/850mg metforminfrom 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.
Relative Bioavailability of Empagliflozin/Metformin Fixed-dose Combination - Empagliflozin 12.5 mg + Metformin 850mg (Boehringer Ingelheim) Coated Tablet Versus Jardiance® 10mg (Reference 1: Boehringer Ingelheim) Coated Tablet and Glifage® 850mg (Reference 2: Merck S / A. ) Coated Tablet, Administered Together in Healthy Male and Female Subjects Under Fed Conditions: an Open-label, Randomised, Single-dose, Two-way Crossover Study
In Brief
A Phase 1 clinical trial evaluating FDC 12.5mg empagliflozin/850mg metformin, Empagliflozin, and 1 other intervention for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBrazil
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartJul 2021
Primary CompletionAug 2021
Study CompletionSep 2021
First PostedOct 2021
TodayJul 2026
First PostedOct 19, 2021
Enrollment StartJul 23, 2021
Primary CompletionAug 6, 2021
Study CompletionSep 9, 2021
TodayJul 2, 2026
Enrollment to primary: 13 daysPosted 4.7 years ago
Interventions
FDC 12.5mg empagliflozin/850mg metformindrug
empagliflozin/metformin
Empagliflozindrug
empagliflozin 10mg (R1)
Glifage®drug
Glifage® 850mg (R2)