Phase 1
Completed N=96
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
Healthy
Source: ClinicalTrials.gov NCT02102932 ↗
Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: AUC(0-∞) for Empagliflozin — 4330; 4110; 1680; 1630 nmol * h/L — p=0.0000
Summary
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-∞) for Empagliflozin |
4330; 4110; 1680; 1630; 4200; 4060 | 0.0000 sig |
| PRIMARY AUC(0-∞) for Metformin |
11600; 11100; 11700; 11000; 7800; 7510 | 0.0001 sig |
| PRIMARY Cmax for Empagliflozin |
644; 605; 263; 237; 569; 561 | 0.0000 sig |
| PRIMARY Cmax for Metformin |
1920; 1830; 1950; 1840; 1290; 1230 | 0.0000 sig |
| SECONDARY AUC(0-tz) of Empagliflozin |
4270; 4060; 1650; 1600; 4140; 4010 | 0.0000 sig |
| SECONDARY AUC(0-tz) of Metformin |
11400; 10800; 11400; 10800; 7630; 7420 | 0.0000 sig |
Eligibility Criteria
Inclusion criteria
Healthy male and female subjects
Exclusion criteria
Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT02102932). 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.