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

October 29, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Morelia, Mexico, 58249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioavailability
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28199

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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