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

Healthy Volunteer Clinical Trial

Official title:
A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01697436
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 1
Start date September 2012
Completion date December 2012
View Details
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