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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00647621 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00647621 record still lists
NCT00647621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Extended Phenytoin Sodium Capsules 100 mg is the first listed.
NCT00647621 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00647621's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia