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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01615393
First received: June 6, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This prospective, randomized, single-blind, cross-over study will compare the bi oavailability of Copegus (ribavirin) administered as tablets and ribavirin admin istered as capsules in healthy volunteers. Volunteers will be randomized to rece ive a single dose of 400 mg of ribavirin either as a capsule or as tablets; afte r a washout phase volunteers will be crossed-over to the other treatment. The an ticipated 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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01615393

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01615393     History of Changes
Other Study ID Numbers: ML28199
Study First Received: June 6, 2012
Last Updated: August 26, 2014
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014