Phase 1
Completed N=64
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
Healthy
Source: ClinicalTrials.gov NCT01276327 ↗
Enrolled (actual)
64
Serious AEs
0.8%
Results posted
Apr 2014
Primary outcomePrimary: AUC0-72 of Linagliptin — 278; 279 nmol*h/L
Summary
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-72 of Linagliptin |
278; 279 | — |
| PRIMARY Cmax of Linagliptin |
8.65; 9.09 | — |
| PRIMARY AUC0-tz of Pioglitazone |
6370; 8100 | — |
| PRIMARY Cmax of Pioglitazone |
806; 843 | — |
| SECONDARY AUC0-tz for Linagliptin |
278; 279 | — |
| SECONDARY AUC0-∞ of Linagliptin |
455; 447 | — |
| SECONDARY AUC0-∞ of Pioglitazone |
6580; 8300 | — |
| SECONDARY Tmax for Linagliptin |
1.73; 1.50 | — |
| SECONDARY Tmax for Pioglitazone |
1.00; 1.50 | — |
Eligibility Criteria
Inclusion criteria
Healthy male and female subjects
Exclusion criteria
Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01276327). 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.