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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 32 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648557
The ClinicalTrials.gov registry entry for NCT00648557 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Levothyroxine Sodium Tablets 200 mg is the first listed.
NCT00648557 reports 0 study locations.
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.
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