Phase 1
Completed N=22
Empa/Lina FDC Food Effect Study (Japan)
Healthy
Source: ClinicalTrials.gov NCT02815644 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Cmax for Linagliptin — 15.1; 8.43 nmol/L
Summary
The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin fixed dose combination (FDC) tablet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax for Linagliptin |
15.1; 8.43 | — |
| PRIMARY Cmax for Empagliflozin |
1010; 756 | — |
| PRIMARY AUC 0-tz for Linagliptin |
348; 286 | — |
| PRIMARY AUC 0-tz for Empagliflozin |
7210; 6200 | — |
| SECONDARY AUC0-infinity for Linagliptin |
597; 526 | — |
| SECONDARY AUC0-infinity for Empagliflozin |
7270; 6280 | — |
| SECONDARY AUC0-72 for Linagliptin |
348; 286 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects age >=20 and =50 kg and =18.0 and <=25.0 kg/m2
- Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
- Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation
Exclusion criteria
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02815644). 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.