A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01615393
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective, randomized, single-blind, cross-over study will compare the bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
- Adult healthy volunteers, 18 to 55 years of age
- Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements
- Body mass index between 18 and 28 kg/m2
- Negative testing for drugs of abuse
Exclusion Criteria
- History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs
- Volunteers require co-medications during the study
- Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start
- Having taken any medication with a clearance period of over seven half-life before study start
- Hospitalization or significant illness 30 days before study start
- Having received a investigational drug within 90 days prior to study start
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ribavirin tablet arm ribavirin [Copegus] - Ribavirin capsule arm ribavirin [Vilona] -
- Primary Outcome Measures
Name Time Method Bioavailability 10 days
- Secondary Outcome Measures
Name Time Method