Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
Status:
Completed
Trial end date:
2015-11-11
Target enrollment:
Participant gender:
Summary
This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting
bipolar Phase III study for New Drug Application (NDA) filing according to regulatory
requirement. The primary objective of this study is to evaluate the PK of lamotrigine
following repeat dosing of lamotrigine dispersible tablet in healthy Chinese subjects. This
study consisted of Screening Phase (Days-14 to 0), Open-label Phase (Days 1 to 51) and
follow-up Phase (10-17 days after last dosing). After signing the informed consent and
confirm the eligibility, subjects will start dosing with lamotrigine 25 mg dispersible tablet
once daily at Day 1 and remain at this dose level for two weeks (Days 1-14), then will be
titrated to 50 mg once daily at Day 15 and last for weeks 3-4 (Days 15-28), and then titrated
to 100 mg once daily at Day 29 during weeks 5-6 (Days 29-42). The total duration of the study
will be approximately 10 weeks including screening and follow-up phase.