MedTrace Logo

A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers

NCT01483729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-11-02

No results posted yet for this study

Summary

This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1, subjects will be randomized to receive single oral doses of one of three tablet formulations of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout between periods. In Part 2, subjects will be randomized to receive single oral doses of one of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.

Conditions

  • Healthy Volunteer

Interventions

DRUG

danoprevir

Phase 3 Tablet Formulation 1, single oral dose

DRUG

danoprevir

Phase 3 Tablet Formulation 2, single oral dose

DRUG

danoprevir

Reference Phase 2 Tablet Formulation, single oral dose

DRUG

ritonavir

Test Formulation 1, single oral dose

DRUG

ritonavir

Test Formulation 2, single oral dose

DRUG

ritonavir

Reference Formulation, single oral dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • New Zealand

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 NCT01483729 on ClinicalTrials.gov