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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 6, 2012
Last updated: October 29, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Healthy Volunteer
Drug: ribavirin [Copegus]
Drug: ribavirin [Vilona]
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Official Title: Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Bioavailability [ Time Frame: 10 days ]

Enrollment: 40
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ribavirin capsule arm Drug: ribavirin [Vilona]
Single oral dose of a 400 mg capsule
Experimental: Ribavirin tablet arm Drug: ribavirin [Copegus]
Single oral dose of 400 mg tablets


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01615393

Morelia, Mexico, 58249
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01615393     History of Changes
Other Study ID Numbers: ML28199
Study First Received: June 6, 2012
Last Updated: October 29, 2016

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents processed this record on April 26, 2017