At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Linagliptin/Metformin (standard batch) +1 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.
Relative Bioavailability of Two Different Batches of a 2.5 mg Linagliptin / 1000 mg Metformin Fixed Dose Combination Tablet (FDC) 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 (standard batch) and Linagliptin/Metformin (side batch) for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedOct 2010
Primary CompletionDec 2010
TodayJul 2026
First PostedOct 7, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.7 years ago
Interventions
Linagliptin/Metformin (standard batch)drug
Fixed dose combination tablet
Linagliptin/Metformin (side batch)drug
Fixed dose combination tablet