At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Metformin +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.
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto® (Two Fixed Dose Combination Tablets of Linagliptin 2.5 mg and Metformin 500 mg) Compared With the Free Combination of Linagliptin 5 mg and Metformin 1000 mg Tablets Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Metformin and Linagliptin for Healthy. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesRussia
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartNov 2013
Primary CompletionJan 2014
TodayJul 2026
First PostedSep 20, 2013
Enrollment StartNov 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.8 years ago
Interventions
Metformindrug
Free combination
Linagliptindrug
Fixed dose combination
Metformindrug
Combination
Linagliptindrug
Free combination