Phase 1
Completed N=68
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT02084082 ↗
Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Aug 2016
Primary outcomePrimary: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) — 286.639; 287.696; 234.052; 221.644 nmol*h/L — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) |
286.639; 287.696; 234.052; 221.644 | <0.0001 sig |
| PRIMARY Maximum Measured Concentration of Linagliptin in Plasma (Cmax) |
8.826; 9.540; 5.791; 5.689 | 0.0038 sig |
| PRIMARY Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
7146.61; 7146.00; 11326.12; 10980.17 | <0.0001 sig |
| PRIMARY Cmax of Metformin in Plasma |
925.709; 923.543; 947.445; 937.685 | <0.0001 sig |
| SECONDARY Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) |
461.306; 460.009; 397.945; 387.424 | <0.0001 sig |
| SECONDARY AUC0-inf of Metformin in Plasma |
7607.75; 7540.21; 15047.37; 14773.59 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Healthy male or female subjects
Exclusion criteria
- Any relevant deviation from healthy condition
Data sourced from ClinicalTrials.gov (NCT02084082). 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.