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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 53 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648778
The ClinicalTrials.gov registry entry for NCT00648778 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 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 Loxapine Succinate Capsules 25 mg is the first listed.
NCT00648778 reports 0 study locations.
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.
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