CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
low dose +2 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/NCT01371006
NCT01371006Phase 1Completed
CompareCT.gov

Effect of Multiple Dosing With 240mg q 12hrs BI 201335 on the Pharmacokinetics of 50 mg Single Dose Efavirenz and Effect of Multiple Dosing With 600mg QD Efavirenz on Cyp 3A4 and the Pharmacokinetics of BI 201335 in Healthy Volunteers

Boehringer Ingelheim·interventional·Posted Jun 10, 2011·Updated Aug 3, 2015

In Brief

A Phase 1 clinical trial evaluating low dose and normal dose for Healthy. Completed, enrolled 29 participants across 1 site.

Detailed Summary

Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together. To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.

Study Details

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

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.1 years ago

Interventions

low dosedrug

efavirenz single dosing once daily

normal dosedrug

efavirenz once daily

low dosedrug

Efavirenz single dosing once daily