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NCT00647855 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00647855: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00647855 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
NCT00647855, 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 levothyroxine sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose pharmacokinetic parameters for baseline corrected total L-thyroxine and non-baseline corrected total L-triiodothyronine were calculated using noncompartmental techniques.
Interventions
- DRUG Levothyroxine Sodium Tablets 300 μg
- DRUG Synthroid® Tablets 300 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2003-05 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
What the finished NCT00647855 record still lists
NCT00647855 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 Levothyroxine Sodium Tablets 300 μg is the first listed.
NCT00647855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00647855 about?
NCT00647855 is a clinical study titled "Fasting Study of Levothyroxine Sodium Tablets 300 μg to Synthroid® Tablets 300 μg". The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Abbott's Synthroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy volunteers under fasting conditions. Single-dose pharmacokinetic parameters for b...
What is the current status of trial NCT00647855?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2003-05. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00647855?
The interventions under investigation include: Levothyroxine Sodium Tablets 300 μg (DRUG), Synthroid® Tablets 300 μg (DRUG).
Who is sponsoring clinical trial NCT00647855?
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 NCT00647855'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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