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NCT01247272 · ClinicalTrials.gov registry record · Phase 1
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01247272: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT01247272 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01247272, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under fasting conditions.
Primary Outcome
Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
Interventions
- DRUG Fluoxetine Hydrochloride
- DRUG PROZAC WEEKLY®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2001-05 |
| Est. Completion | 2001-07 |
| Phase | Phase 1 |
What the finished NCT01247272 record still lists
NCT01247272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine Hydrochloride is the first listed.
NCT01247272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01247272 about?
NCT01247272 is a clinical study titled "90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions". This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under fast...
What is the current status of trial NCT01247272?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2001-05. Estimated completion is 2001-07.
What interventions are being tested in trial NCT01247272?
The interventions under investigation include: Fluoxetine Hydrochloride (DRUG), PROZAC WEEKLY® (DRUG).
Who is sponsoring clinical trial NCT01247272?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01247272's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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