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NCT00648778 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT00648778: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648778 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648778, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan loxapine succinate 25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administration under fasting conditions.
Interventions
- DRUG Loxapine Succinate Capsules 25 mg
- DRUG Loxitane® Capsules 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2003-01 |
| Est. Completion | 2003-02 |
| Phase | Phase 1 |
What the finished NCT00648778 record still lists
NCT00648778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Loxapine Succinate Capsules 25 mg is the first listed.
NCT00648778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648778 about?
NCT00648778 is a clinical study titled "Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg". The objective of this study was to investigate the bioequivalence of Mylan loxapine succinate 25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administration under fasting conditions.
What is the current status of trial NCT00648778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2003-01. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00648778?
The interventions under investigation include: Loxapine Succinate Capsules 25 mg (DRUG), Loxitane® Capsules 25 mg (DRUG).
Who is sponsoring clinical trial NCT00648778?
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 NCT00648778's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 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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