deleobuvir (BI 207127) - Boehringer Ingelheim
Bioavailability of 3 different formulations of BI 207127 (clinicaltrials.gov) - Apr 4, 2012 - P1, N=18; Recruiting -> Completed 
Trial completion • Hepatitis C Virus
http://clinicaltrials.gov/ct2/show/NCT01535638
 
Apr 4, 2012
 
This study has been completed. First Received on February 15, 2012.   Last Updated on April 4, 2012   History of Changes Sponsor: Boehringer Ingelheim Pharmaceuticals Information provided by (Responsible Party): Boehringer Ingelheim Pharmaceuticals ClinicalTrials.gov Identifier: NCT01535638   Purpose The primary objective of the current study is to investigate the relative bioavailability of three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy volunteers, with the aim to compare the bioavailability of the three formulations. All treatments will be applied fed, 30 minutes after start of the intake of a standard normal breakfast. Condition          Healthy Intervention Drug: BI 207127 Phase Phase I Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Relative Bioavailability of BI 207127 FF Tablets, BI 207127 FF Modified Tablets and BI 207127 TFII Tablets Administered Orally as Three Tablets (Single Dose) to Healthy Male Volunteers, an Open-label, Randomised Three-way Crossover Study Further study details as provided by Boehringer Ingelheim Pharmaceuticals: Primary Outcome Measures: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ] Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ] Enrollment: 18 Study Start Date: February 2012 Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)