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NCT00648440 · ClinicalTrials.gov registry record · Phase 1
Food 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
- 36
- Enrollment target
NCT00648440 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants.
The verdict
NCT00648440, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 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 | 36 participants |
| Start Date | 2002-10 |
| Est. Completion | 2002-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648440
The ClinicalTrials.gov registry entry for NCT00648440 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Midodrine HCl Tablets 5 mg is the first listed.
NCT00648440 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00648440 about?
NCT00648440 is a clinical study titled "Food 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 NCT00648440?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2002-10. Estimated completion is 2002-11.
What interventions are being tested in trial NCT00648440?
The interventions under investigation include: Midodrine HCl Tablets 5 mg (DRUG), ProAmatine® Tablets 5 mg (DRUG).
Who is sponsoring clinical trial NCT00648440?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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