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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: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00650208 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00650208 record still lists
NCT00650208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine Tablets 25 mg is the first listed.
NCT00650208 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00650208's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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