Pharmacokinetics Clinical Trial
Official title:
A Different Level of Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics of Bilastine in a Chinese Population
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK) study which will be conducted in Phase I Clinical Trial Centre, Chinese University of Hong Kong, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose of bilastine in healthy Chinese subjects.
This is a single-dose and multiple-dose, open-label, single-centre pharmacokinetic (PK)
study, to evaluate pharmacokinetics (PK) of different levels of single-dose and multiple-dose
of bilastine in healthy Chinese subjects. Total 24 subjects will be enrolled into the study
and divided into 2 cohorts, 12 subjects in each cohort.
Single-dose only cohort treatment duration is 1 day and receive a single dose of 40 mg of
bilastine then collect PK blood sample. Single-dose followed by multiple-dose cohort
treatment duration of this cohort is 9 days. Subjects will receive a single dose of bilastine
20 mg on the morning of Day 1; and six doses of bilastine 20 mg in the morning from Day 4 to
Day 9 and collect PK blood samples. The primary objective of the study is to determine the PK
properties of orally administered bilastine in healthy Chinese population. The secondary
objective of the study is to evaluate the safety and tolerability of bilastine administered
as a single and multiple doses in healthy Chinese subjects.
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