drugset / Trial / NCT05145608
Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg
RandomizedCrossoverOpen-labelOther
Summary
Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions. The secondary objective is to monitor the safety of the subjects.
Timeline
- Start
- 2018-01-10
- Primary completion
- 2018-02-21
- Completion
- 2018-02-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lamotrigine | Small molecule | 50 mg | Oral |
Indications
No indication recorded.