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NCT00650013 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00650013: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00650013 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650013, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
Interventions
- DRUG Midodrine HCl Tablets 5 mg
- DRUG ProAmatine® Tablets 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2002-07 |
| Est. Completion | 2002-08 |
| Phase | Phase 1 |
What the finished NCT00650013 record still lists
NCT00650013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Midodrine HCl Tablets 5 mg is the first listed.
NCT00650013 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00650013 about?
NCT00650013 is a clinical study titled "Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg". The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
What is the current status of trial NCT00650013?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2002-07. Estimated completion is 2002-08.
What interventions are being tested in trial NCT00650013?
The interventions under investigation include: Midodrine HCl Tablets 5 mg (DRUG), ProAmatine® Tablets 5 mg (DRUG).
Who is sponsoring clinical trial NCT00650013?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00650013's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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