At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Linagliptin/metformin +2 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 Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)
In Brief
A Phase 1 clinical trial evaluating Linagliptin/metformin, Metformin, and 1 other intervention for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionJun 2012
TodayJul 2026
First PostedApr 20, 2012
Enrollment StartApr 1, 2012
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.2 years ago
Interventions
Linagliptin/metformindrug
FDC
Metformindrug
single tablet Metformin
Linagliptindrug
single tablet Linagliptin