Phase 1
Completed N=23
Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT01284621 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss) — 5850; 5680 nmol*h/L
Summary
Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if ramipril affects the pharmacokinetics of BI 10773.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss) |
5850; 5680 | — |
| PRIMARY Total Empa: Maximum Measured Concentration (Cmax,ss) |
874; 911 | — |
| PRIMARY Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss). |
6.59; 7.27 | — |
| PRIMARY Total Ramipril: Maximum Measured Concentration (Cmax,ss) |
8.42; 8.97 | — |
| PRIMARY Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss). |
87.2; 85.1 | — |
| PRIMARY Total Ramiprilat: Maximum Measured Concentration (Cmax,ss) |
11.2; 10.5 | — |
| SECONDARY Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N) |
40.3; 38.6; 45.8; 45.1; 49.2; 46.4 | — |
| SECONDARY Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N) |
1.03; 1.02; 1.33; 1.31; 1.39; 1.37 | — |
| SECONDARY Time From Last Dosing to the Maximum Measured Concentration (Tmax,ss) |
1.02; NA; 1.50; NA; 0.333; 0.333 | — |
| SECONDARY Terminal Rate Constant (λz,ss) |
0.055; NA; 0.050; NA; 0.261; 0.298 | — |
| SECONDARY Terminal Half-life (T 1/2,ss) |
12.7; NA; 13.9; NA; 2.66; 2.32 | — |
| SECONDARY Mean Residence Time (MRTpo,ss) |
9.95; NA; 9.68; NA; 1.29; 1.42 | — |
| SECONDARY Apparent Clearance After Extravascular Administration (CL/Fss) |
158; NA; 163; NA; 12600; 11500 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase (Vz/Fss) |
174; NA; 196; NA; 2910; 2310 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Tolerability |
0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- healthy male and female subjects
Exclusion criteria
- Any relevant deviation from healthy conditions.
Data sourced from ClinicalTrials.gov (NCT01284621). 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.