At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 58 enrolled
Drug / intervention
Metformin Single Tablet +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.
A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Metformin Single Tablet, Linagliptin/Metformin Combo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionDec 2011
TodayJul 2026
First PostedJun 28, 2011
Enrollment StartJun 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.0 years ago
Interventions
Metformin Single Tabletdrug
Metformin medium doseTablet
Linagliptin/Metformin Combodrug
Fixed dose combination
Linagliptin Single Tabletdrug
Linagliptin Single medium dose Tablet