Phase 1
N=32
Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01581931 ↗Enrolled (actual)
32
Serious AEs
1.6%
Results posted
Aug 2013
Primary outcome: Primary: Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin — 7219.03; 7057.52 ng·h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Linagliptin/metformin (Drug); Metformin (Drug); Linagliptin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin |
7219.03; 7057.52 | — |
| PRIMARY Maximum Concentration (Cmax) of Metformin |
855.09; 844.72 | — |
| SECONDARY Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin |
7343.59; 7174.30 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Metformin |
4.00; 4.00 | — |
| SECONDARY Terminal Half-life t1/2 of Metformin |
9.14; 8.03 | — |
Summary
To establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin
Eligibility Criteria
Inclusion criteria
- Healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01581931). 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.