At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 68 enrolled
Drug / intervention
Linagliptin/Metformin ER FDC +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 (5 mg/1000 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/Metformin ER FDC, Linagliptin, and 1 other intervention for Healthy. Completed, enrolled 68 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, both under fed and fasted conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
CollaboratorsEli Lilly and Company
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionJul 2014
TodayJul 2026
First PostedMar 11, 2014
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.3 years ago
Interventions
Linagliptin/Metformin ER FDCdrug
1x Linagliptin/Metformin FDC tablet
Linagliptindrug
1x Linagliptin tablet
Metformin ERdrug
2x Metformin ER tablets