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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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
Ethnic Chinese males and females between 18 and 45 years of age (inclusive).
Having voluntarily given their informed consent to participate in the study after receiving information about the design, aims and potential risks that could result from the study and being informed that they could refuse to take part in or withdraw from the study at any time.
Body mass of no less than 50 kg. Body mass index: 19 to 24 kg/m2 (inclusive).
No clinically significant abnormal findings from the physical examination, vital signs check, electrocardiogram (ECG), medical history, or clinical laboratory results during screening and pre-dosing of Day 1.
A negative screen for HIV and hepatitis B.
A negative urine or breathalyzer screen for alcohol and negative urine screen for drugs of abuse.
Are non-tobacco / nicotine users (within 3 months prior to screening visit).
A negative serum pregnancy test for female subjects.
Subjects who are willing to comply with the contraception restrictions for this study:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
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Central trial contact
Maria Carolina De Quiroz, MD
Data sourced from clinicaltrials.gov
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