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Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir

NCT01694706 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-07-30

Study results available
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Summary

The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.

Conditions

  • Healthy

Interventions

DRUG

faldaprevir

medium dose of faldaprevir

DRUG

faldaprevir

medium dose of faldaprevir

DRUG

omeprazole

medium dose of omeprazole

DRUG

faldaprevir

medium dose of faldaprevir

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694706 on ClinicalTrials.gov