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NCT01697436 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01697436 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants.
The verdict
NCT01697436, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
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.
Interventions
- DRUG ribavirin [Copegus]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697436
The ClinicalTrials.gov registry entry for NCT01697436 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ribavirin [Copegus] is the first listed.
NCT01697436 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01697436 about?
NCT01697436 is a clinical study titled "A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets". 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 w...
What is the current status of trial NCT01697436?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01697436?
The interventions under investigation include: ribavirin [Copegus] (DRUG).
Who is sponsoring clinical trial NCT01697436?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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