At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
BI 409306drug
Likely dose
Not stated in 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.
Open, Randomised, Two-way Crossover Study to Assess the Effect of a High Fat, High Caloric Meal on the Pharmacokinetics of BI 409306, Followed by a Fixed Sequence Period to Investigate the Pharmacokinetics of BI 409306 After a Single Oral Dose Given at Bed Time in Healthy Male and Female Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 409306 for Healthy. Completed, enrolled 18 participants across 1 site.
Detailed Summary
To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartSep 2014
Primary CompletionOct 2014
TodayJul 2026
First PostedAug 21, 2014
Enrollment StartSep 4, 2014
Primary CompletionOct 31, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.9 years ago
Interventions
BI 409306drug
film-coated tablet