Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China
Status:
Completed
Trial end date:
2011-05-23
Target enrollment:
Participant gender:
Summary
It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four
eligible, healthy, Chinese male subjects will be enrolled after providing written informed
consent. Subjects will be randomised into two treatment groups 1 day prior to the first
dosing day and will be assigned to regimen sequences (AB or BA) in a balanced fashion in
accordance with the randomisation schedule. Regimen A is five lamotrigine 5 mg
chewable/dispersible tablets and Regimen B is one lamotrigine 25 mg standard/compressed
tablet.
Subjects will receive their allocated regimen on the morning of Day 1 and will undergo study
assessments for 7 days (until Day 8). Subjects will receive their alternate randomised
treatment after a washout period of 14-21 days from Day 1. Subjects will undergo a further
assessment period of 7 days and will attend a follow-up visit during 8-12 days after the
second treatment. The total observation period in this study will be 23~34 days.
Subjects will arrive at the research unit on the evening before each lamotrigine dosing
occasion and will remain in the unit until the 24-h post-dose evaluations have been completed
(pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 h). After this, subjects will return
home but must return to the unit for further assessments to be made at 36, 48, 72, 96, 120,
144 and 168 h after dosing Study Endpoints/Assessments A total of 19 serial blood samples (5
mL each) will be collected for the measurement of plasma lamotrigine concentrations at each
study assessment. Safety and tolerability assessments (monitoring of adverse events and
serious adverse events, routine laboratory determinations, vital sign measurements and
12-lead electrocardiogram) will be conducted throughout the study.