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NCT00648557 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00648557: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00648557 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00648557, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, two-period, two-treatment, single-dose crossover study conducted by Dr. James D. Carlson at PRACS Institute, Ltd., Fargo, ND. Statistical analysis of the data revealed that 90% confidence intervals were within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters LNAUC0-48hr and LNCPEAK for baseline corrected total L-thyroxine. This study demonstrated that Mylan's 200 μg levothyroxine sodium tablets are bioequivalent to Abbott's Synthroid® 200 μg tablets following a single, oral 600 μg (3 x 200 μg) dose under fasting conditions
Interventions
- DRUG Levothyroxine Sodium Tablets 200 mg
- DRUG Synthroid Tablets 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2003-01 |
| Est. Completion | 2003-03 |
| Phase | Phase 1 |
What the finished NCT00648557 record still lists
NCT00648557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Levothyroxine Sodium Tablets 200 mg is the first listed.
NCT00648557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00648557 about?
NCT00648557 is a clinical study titled "Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg". The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects...
What is the current status of trial NCT00648557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2003-01. Estimated completion is 2003-03.
What interventions are being tested in trial NCT00648557?
The interventions under investigation include: Levothyroxine Sodium Tablets 200 mg (DRUG), Synthroid Tablets 200 mg (DRUG).
Who is sponsoring clinical trial NCT00648557?
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 NCT00648557's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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