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NCT00648063 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00648063: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
NCT00648063 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648063, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.
Conditions Studied
Interventions
- DRUG Letrozole Tablets 2.5 mg
- DRUG Femara® Tablets 2.5 mg
Study Locations (1)
Florida
- SFBC International - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-01 |
| Phase | Phase 1 |
What the finished NCT00648063 record still lists
NCT00648063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Letrozole Tablets 2.5 mg is the first listed.
NCT00648063 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00648063 about?
NCT00648063 is a clinical study titled "Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg". The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.
What is the current status of trial NCT00648063?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2005-11. Estimated completion is 2006-01.
What conditions does trial NCT00648063 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00648063?
The interventions under investigation include: Letrozole Tablets 2.5 mg (DRUG), Femara® Tablets 2.5 mg (DRUG).
Who is sponsoring clinical trial NCT00648063?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00648063 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00648063's enrollment target sits among peer trials
24 791st of 1090 higher than 254 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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