Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00647621 · ClinicalTrials.gov registry record · Phase 1
Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00647621 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 72 participants.
The verdict
NCT00647621, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.
Interventions
- DRUG Extended Phenytoin Sodium Capsules 100 mg
- DRUG Dilantin® Kapseals® 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2005-10 |
| Est. Completion | 2005-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00647621
The ClinicalTrials.gov registry entry for NCT00647621 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 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 Extended Phenytoin Sodium Capsules 100 mg is the first listed.
NCT00647621 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00647621 about?
NCT00647621 is a clinical study titled "Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg". The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.
What is the current status of trial NCT00647621?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2005-10. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00647621?
The interventions under investigation include: Extended Phenytoin Sodium Capsules 100 mg (DRUG), Dilantin® Kapseals® 100 mg (DRUG).
Who is sponsoring clinical trial NCT00647621?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.