drugset / Trial / NCT02821338
A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
Phase 1
Completed
30 enrolled
Food and Drug Administration (FDA)
Algorithme Pharma Inc · collabVince & Associates Clinical Research, Inc. · collab
RandomizedCrossoverOpen-labelOther
Summary
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.
Timeline
- Start
- 2016-06
- Primary completion
- 2016-09
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lamotrigine | Small molecule | — | Oral |
Indications
No indication recorded.