At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
Linagliptin + Pioglitazone +3 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 a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)
In Brief
A Phase 1 clinical trial evaluating Linagliptin + Pioglitazone and Linagliptin/Pioglitazone for Healthy. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionMay 2011
TodayJul 2026
First PostedJan 13, 2011
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.5 years ago
Interventions
Linagliptin + Pioglitazonedrug
Medium doses, oral administration
Linagliptin + Pioglitazonedrug
Medium doses, oral administration
Linagliptin/Pioglitazonedrug
Medium dose oral administration
Linagliptin/Pioglitazonedrug
Medium dose oral administration