Phase 1
Completed N=72
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Healthy
Source: ClinicalTrials.gov NCT01845077 ↗
Enrolled (actual)
72
Serious AEs
0.7%
Results posted
Aug 2014
Primary outcomePrimary: AUC0-72 of Linagliptin — 317.0; 319.2; 309.6; 304.9 nmol*h/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-72 of Linagliptin |
317.0; 319.2; 309.6; 304.9; 325.8; 322.9 | — |
| PRIMARY Cmax of Linagliptin |
10.1; 10.6; 7.7; 7.9; 11.6; 10.7 | — |
| PRIMARY AUC0-tz of Metformin |
8629.0; 8913.7; 13772.0; 13851.1; 10472.9; 10543.5 | — |
| PRIMARY Cmax of Metformin |
1047.4; 1085.6; 1119.0; 1084.5; 1347.0; 1250.6 | — |
| SECONDARY AUC0-infinity of Linagliptin |
546.1; 526.5; 537.1; 510.0; 562.9; 581.1 | — |
| SECONDARY AUC0-infinity of Metformin |
9037.6; 9326.5; 14031.3; 14069.7; 11037.7; 11512.2 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males or females
- Age 18 -50 years (incl)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Subjects must be able to understand and comply with study requirements
Exclusion criteria
Any deviation from healthy condition
Data sourced from ClinicalTrials.gov (NCT01845077). 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.