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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00647855
The ClinicalTrials.gov registry entry for NCT00647855 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 300 μg is the first listed.
NCT00647855 reports 0 study locations.
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.
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