A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615393
• Other study ID #: ML28199
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: October 29, 2016
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ribavirin [Copegus]
Single oral dose of 400 mg tablets
• ribavirin [Vilona]
Single oral dose of a 400 mg capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability		10 days	No