At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
2x500 mg Metformin (Glumetza) +8 moredrug
Likely dose
5 mg Linagliptin/1000 mg Metformin FDCfrom 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 Newly Developed Extended Release FDC Tablet Strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin Extended Release Compared With the Free Combination of Linagliptin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
In Brief
A Phase 1 clinical trial evaluating 2x500 mg Metformin (Glumetza), 5 mg Linagliptin/1000 mg Metformin FDC, and 5 other interventions for Healthy. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsEli Lilly and Company
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionAug 2013
TodayJul 2026
First PostedMay 3, 2013
Enrollment StartMay 1, 2013
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.2 years ago
Interventions
2x500 mg Metformin (Glumetza)drug
2 tablets
5 mg Linagliptin/1000 mg Metformin FDCdrug
FDC tablet
5 mg Linagliptin (Tradjenta)drug
1 tablet
5 mg Linagliptin (Tradjenta)drug
1 tablet
3x500 mg Metformin (Glumetza)drug
3 tablets
5 mg Linagliptin (Tradjenta)drug
1 tablet
2 x 500 mg Metformin (Glumetza)drug
2 tablets
5 mg Linagliptin/1000mg Metformin FDCdrug
FDC Tablet
2 x 2.5 mg Linagliptin/750 mg Metformin FDCdrug
2 FDC tablets