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NCT01074450 · ClinicalTrials.gov registry record · Phase 1
Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01074450: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01074450 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01074450, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under fasting conditions.
Primary Outcome
Bioequivalence based on Cmax.
Interventions
- DRUG Pramipexole Dihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-02 |
| Est. Completion | 2005-03 |
| Phase | Phase 1 |
What the finished NCT01074450 record still lists
NCT01074450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Pramipexole Dihydrochloride is the first listed.
NCT01074450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01074450 about?
NCT01074450 is a clinical study titled "Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions". The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose ...
What is the current status of trial NCT01074450?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2005-02. Estimated completion is 2005-03.
What interventions are being tested in trial NCT01074450?
The interventions under investigation include: Pramipexole Dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT01074450?
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 NCT01074450's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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