At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 74 enrolled
Drug / intervention
Linagliptin +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 a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/750 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)
In Brief
A Phase 1 clinical trial evaluating Linagliptin, Linagliptin/Metformin ER FDC, and 1 other intervention for Healthy. Completed, enrolled 74 participants across 1 site.
Detailed Summary
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
CollaboratorsEli Lilly and Company
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionJul 2014
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartMay 1, 2014
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.2 years ago
Interventions
Linagliptindrug
1 x Linagliptin tablet
Linagliptin/Metformin ER FDCdrug
2 x Linagliptin/Metformin ER FDC tablet
Metformin ERdrug
3 x Metformin ER tablets