Phase 1
Completed N=16
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
Source: ClinicalTrials.gov NCT01211197 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcomePrimary: Empa: Area Under the Curve 0 to Infinity (AUC0-∞) — 2920; 2860; 2710 nmol*h/L
Summary
The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Empa: Area Under the Curve 0 to Infinity (AUC0-∞) |
2920; 2860; 2710 | — |
| PRIMARY Empa: Maximum Measured Concentration (Cmax) |
404; 405; 259 | — |
| PRIMARY Metformin: Area Under the Curve 0 to Infinity (AUC0-∞) |
10300; 10100; 10200 | — |
| PRIMARY Metformin: Maximum Measured Concentration (Cmax) |
1550; 1530; 1180 | — |
| SECONDARY Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
2860; 2800; 2640 | — |
| SECONDARY Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz) |
9900; 9720; 9550 | — |
| SECONDARY Time to Maximum Measured Concentration (Tmax) |
1.50; 1.75; 3.00; 2.50; 2.50; 3.00 | — |
| SECONDARY Terminal Elimination Rate Constant in Plasma (λz) |
0.0559; 0.0601; 0.0498; 0.0822; 0.0756; 0.0590 | — |
| SECONDARY Terminal Half-life in Plasma (T1/2) |
15.1; 16.0; 16.7; 16.6; 17.8; 30.5 | — |
| SECONDARY Mean Residence Time in the Body After Oral Administration (MRTpo) |
10.5; 10.9; 13.9; 9.53; 10.2; 19.4 | — |
| SECONDARY Apparent Clearance After Extravascular Administration (CL/F) |
162; 166; 174; 1670; 1730; 1670 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase (Vz/F) |
210; 222; 250; 2410; 2650; 4670 | — |
| SECONDARY Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. |
0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males and females according to the following criteria
- Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
Exclusion criteria
- Any finding of the medical examination (including Blood Pressure, Pulse Rate and electrocardiogram) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
Data sourced from ClinicalTrials.gov (NCT01211197). 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.