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NCT00649636 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00649636 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 32 participants.
The verdict
NCT00649636, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting conditions.
Interventions
- DRUG Fluoxetine Capsules 40 mg
- DRUG Prozac Pulvules 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649636
The ClinicalTrials.gov registry entry for NCT00649636 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 Fluoxetine Capsules 40 mg is the first listed.
NCT00649636 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00649636 about?
NCT00649636 is a clinical study titled "Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg". The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting conditions.
What is the current status of trial NCT00649636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-02. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00649636?
The interventions under investigation include: Fluoxetine Capsules 40 mg (DRUG), Prozac Pulvules 40 mg (DRUG).
Who is sponsoring clinical trial NCT00649636?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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