Trials / Completed
CompletedNCT00834561
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
Randomized, Two-Way Crossover, Single-Dose, Fasting Bioequivalence Study of Lamotrigine 1 x 200 mg Tablet
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lamotrigine | 200 mg Tablet |
| DRUG | Lamictal® | 200 mg Tablet |
Timeline
- Start date
- 2002-01-01
- Primary completion
- 2002-02-01
- Completion
- 2002-02-01
- First posted
- 2009-02-03
- Last updated
- 2024-08-19
- Results posted
- 2009-08-04
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00834561. Inclusion in this directory is not an endorsement.