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NCT00449774 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
NCT00449774: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00449774 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 220 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00449774, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
Study Summary
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
Interventions
- DRUG Lamotrigine IR tablets
- DRUG Lamotrigine ODT tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2007-05-07 |
| Est. Completion | 2007-06-19 |
| Phase | Phase 1 |
What the finished NCT00449774 record still lists
NCT00449774 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher).
The record links to 0 conditions, and to 2 interventions - of which Lamotrigine IR tablets is the first listed.
NCT00449774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00449774 about?
NCT00449774 is a clinical study titled "Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers". This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
What is the current status of trial NCT00449774?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2007-05-07. Estimated completion is 2007-06-19.
What interventions are being tested in trial NCT00449774?
The interventions under investigation include: Lamotrigine IR tablets (DRUG), Lamotrigine ODT tablets (DRUG).
Who is sponsoring clinical trial NCT00449774?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00449774's enrollment target sits among peer trials
220 230th of 2000 higher than 1,763 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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