drugset / Trial / NCT00838136
Lamotrigine 25 mg Chewable Tablets, Non-Fasting
RandomizedCrossoverOpen-labelOther
Summary
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fed conditions.
Timeline
- Start
- 2002-02
- Primary completion
- 2002-03
- Completion
- 2002-03
Outcome
Met primary endpoint
registry Test/Ref Ratio of LS Means x 100 101.23 (90% CI 99.88 to 102.60) NCT00838136 ↗
registry Test/Ref Ratio of LS Means x 100 101.87 (90% CI 99.18 to 104.63) NCT00838136 ↗
registry Test/Ref Ratio of LS Means x 100 100.76 (90% CI 98.60 to 102.97) NCT00838136 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamotrigine | Small molecule | 50 mg | — |
Indications
No indication recorded.