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A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets

NCT01697436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-02

No results posted yet for this study

Summary

This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four sequences in which they will receive the treatment under fed and under fasted conditions.

Conditions

  • Healthy Volunteer

Interventions

DRUG

ribavirin [Copegus]

tablet under fed condition

DRUG

ribavirin [Copegus]

tablet under fasted condition

DRUG

ribavirin [Copegus]

oral solution under fed condition

DRUG

ribavirin [Copegus]

oral solution under fasted condition

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697436 on ClinicalTrials.gov