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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribavirin capsule arm | Active Comparator |
| |
| Ribavirin tablet arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ribavirin [Copegus] | Drug | Single oral dose of 400 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morelia | 58249 | Mexico |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| ribavirin [Vilona] |
| Drug |
Single oral dose of a 400 mg capsule |
|