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

NCT01615393 | Completed Phase 1

• 1 other identifier: ML28199
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Bioavailability

  10 days

Study Arms (2)

Ribavirin capsule arm

ACTIVE COMPARATOR

Drug: ribavirin [Vilona]

Ribavirin tablet arm

EXPERIMENTAL

Drug: ribavirin [Copegus]

Interventions

ribavirin [Copegus] DRUG

Single oral dose of 400 mg tablets

Ribavirin tablet arm

ribavirin [Vilona] DRUG

Single oral dose of a 400 mg capsule

Ribavirin capsule arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Morelia, 58249, Mexico

Location

MeSH Terms

Interventions

Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

ME (1)