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NCT00648921 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00648921: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648921 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648921, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fasting conditions.
Interventions
- DRUG Olanzapine Tablets 5 mg
- DRUG Zyprexa® Tablets 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2003-06 |
| Est. Completion | 2003-07 |
| Phase | Phase 1 |
What the finished NCT00648921 record still lists
NCT00648921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Olanzapine Tablets 5 mg is the first listed.
NCT00648921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648921 about?
NCT00648921 is a clinical study titled "Fasting Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg". The objective of this study was to investigate the bioequivalence of Mylan's olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fasting conditions.
What is the current status of trial NCT00648921?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2003-06. Estimated completion is 2003-07.
What interventions are being tested in trial NCT00648921?
The interventions under investigation include: Olanzapine Tablets 5 mg (DRUG), Zyprexa® Tablets 5 mg (DRUG).
Who is sponsoring clinical trial NCT00648921?
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 NCT00648921's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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