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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648063
The ClinicalTrials.gov registry entry for NCT00648063 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.