Phase 1
Completed N=74
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
Healthy
Source: ClinicalTrials.gov NCT02084056 ↗
Enrolled (actual)
74
Serious AEs
0.0%
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) — 278.460; 288.709; 264.509; 268.814 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.
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) |
278.460; 288.709; 264.509; 268.814 | <0.0001 sig |
| PRIMARY Maximum Measured Concentration of Linagliptin in Plasma (Cmax) |
8.274; 9.480; 6.729; 6.613 | 0.0113 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) |
12028.27; 11601.19; 20411.01; 19952.61 | <0.0001 sig |
| PRIMARY Cmax of Metformin in Plasma |
1516.558; 1485.642; 1571.040; 1662.954 | <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) |
457.780; 473.704; 445.884; 451.888 | <0.0001 sig |
| SECONDARY AUC0-inf of Metformin in Plasma |
12736.87; 12162.37; 20721.20; 20346.34 | <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 (NCT02084056). 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.