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

NCT ID: NCT01615393

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Ribavirin capsule arm

Group Type ACTIVE_COMPARATOR

ribavirin [Vilona]

Intervention Type DRUG

Single oral dose of a 400 mg capsule

Ribavirin tablet arm

Group Type EXPERIMENTAL

ribavirin [Copegus]

Intervention Type DRUG

Single oral dose of 400 mg tablets

Interventions

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ribavirin [Copegus]

Single oral dose of 400 mg tablets

Intervention Type DRUG

ribavirin [Vilona]

Single oral dose of a 400 mg capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Morelia, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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ML28199

Identifier Type: -

Identifier Source: org_study_id