Healthy Volunteer
Conditions
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.
Interventions
Single oral dose of 400 mg tablets
DRUGribavirin [Vilona]
Single oral dose of a 400 mg capsule
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioavailability | 10 days |
Countries
Mexico
Outcome results
None listed