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OpenTrials
Completed

NCT Number: NCT01615393

A Study to Compare the Bioavailability of Copegus and 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Morelia, 58249, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ribavirin [Copegus]

Drug

Single oral dose of 400 mg tablets

ribavirin [Vilona]

Drug

Single oral dose of a 400 mg capsule

Primary outcomes

  1. Bioavailability

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 8, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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