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

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ClinicalTrials.gov Identifier: NCT01615393
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: ribavirin [Copegus] Drug: ribavirin [Vilona] Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Bioavailability [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615393


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01615393     History of Changes
Other Study ID Numbers: ML28199
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

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