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A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers

NCT01612143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-02

No results posted yet for this study

Summary

This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.

Conditions

  • Healthy Volunteer

Interventions

DRUG

setrobuvir

200 mg capsule formulation, single oral dose

DRUG

setrobuvir

200 mg tablet formulation, single oral dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Netherlands

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 NCT01612143 on ClinicalTrials.gov