Phase 1
Completed N=15
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Healthy
Source: ClinicalTrials.gov NCT01703858 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 936; 924; 648; 900 nanomol (nmol)* hours (h) / Litre (L) — p=0.0000
Summary
The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
936; 924; 648; 900; 759 | 0.0000 sig |
| PRIMARY Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax) |
271; 242; 132; 196; 227 | 0.1261 |
| SECONDARY Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) |
938; 926; 650; 902; 761 | 0.0000 sig |
Eligibility Criteria
Inclusion criteria
- healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01703858). 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.