At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
BI 113608 PIB +5 moredrug
Likely dose
pantoprazole 40 mg STADAfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608
In Brief
A Phase 1 clinical trial evaluating BI 113608 PIB, BI 113608, and 1 other intervention for Healthy. Completed, enrolled 15 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedOct 2012
Primary CompletionJan 2013
TodayJul 2026
First PostedOct 11, 2012
Enrollment StartSep 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.7 years ago
Interventions
BI 113608 PIBdrug
powder for oral solution
BI 113608drug
conventional tablet formulation
BI 113608drug
conventional tablet formulation
BI 113608drug
conventional tablet formulation
pantoprazole 40 mg STADAdrug
film-coated tablet
BI 113608drug
conventional tablet formulation