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NCT00835146 · ClinicalTrials.gov registry record · Phase 1
Ribavirin 200 mg Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00835146: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00835146 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835146, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The objective of this study is to compare the relative bioavailability of ribavirin 200 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult, non-smoking, females (who are unable to become pregnant) under fasting conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Ribavirin 200 mg tablets
- DRUG COPEGUS™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2003-09 |
| Est. Completion | 2003-10 |
| Phase | Phase 1 |
What the finished NCT00835146 record still lists
NCT00835146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin 200 mg tablets is the first listed.
NCT00835146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835146 about?
NCT00835146 is a clinical study titled "Ribavirin 200 mg Tablets Under Fasting Conditions". The objective of this study is to compare the relative bioavailability of ribavirin 200 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult, non-smoking, females (who are unable t...
What is the current status of trial NCT00835146?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2003-09. Estimated completion is 2003-10.
What interventions are being tested in trial NCT00835146?
The interventions under investigation include: Ribavirin 200 mg tablets (DRUG), COPEGUS™ (DRUG).
Who is sponsoring clinical trial NCT00835146?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835146's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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