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NCT00650208 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT00650208 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 27 participants.
The verdict
NCT00650208, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fasting conditions.
Interventions
- DRUG Lamotrigine Tablets 25 mg
- DRUG Lamictal® Tablets 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2004-07 |
| Est. Completion | 2004-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00650208
The ClinicalTrials.gov registry entry for NCT00650208 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 Lamotrigine Tablets 25 mg is the first listed.
NCT00650208 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00650208 about?
NCT00650208 is a clinical study titled "Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg". The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fasting conditions.
What is the current status of trial NCT00650208?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2004-07. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00650208?
The interventions under investigation include: Lamotrigine Tablets 25 mg (DRUG), Lamictal® Tablets 25 mg (DRUG).
Who is sponsoring clinical trial NCT00650208?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
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