Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
Status:
Completed
Trial end date:
2016-01-26
Target enrollment:
Participant gender:
Summary
This study is an open-label, 2-way crossover, single-dose study that is being performed to
establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers:
manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial
drug product. This bioequivalence study will confirm (1) the drug product manufactured from
these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data
obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.