CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
BI 409306 +1 moredrug
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.

Search/NCT03151499
NCT03151499Phase 1Completed
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Effect of Rifampicin on the Pharmacokinetics of BI 409306 Following Oral Administration in Healthy Male Subjects (an Open-label, Two-period, Fixed Sequence Trial)

Boehringer Ingelheim·interventional·Posted May 12, 2017·Updated Mar 7, 2024

In Brief

A Phase 1 clinical trial evaluating BI 409306 and Rifampicin for Healthy. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306 tablets without prior administration of rifampicin (Reference, R) following oral administration in healthy male subjects. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments. The secondary objectives will be assessed by descriptive statistics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartMay 30, 2017
Primary CompletionJul 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.1 years ago

Interventions

BI 409306drug

Reference and Test Treatment

Rifampicindrug

Test Treatment