Phase 1
Completed N=58
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Source: ClinicalTrials.gov NCT01383356 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 901.82; 770.52 ng/ml
Summary
The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
901.82; 770.52 | — |
| PRIMARY Area Under the Curve 0 to Last Measurable Value (AUC0-t) |
7079.65; 6808.27 | — |
| SECONDARY Area Under the Curve 0 to Inf (AUC0-inf) |
7198.79; 6923.79 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects.
Exclusion criteria
- Any relevant deviation from healthy conditions.
Data sourced from ClinicalTrials.gov (NCT01383356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.