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Different Level of Single-dose and Multiple-dose Bilastine PK Study in Chinese Population

NCT03633760 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-01-10

No results posted yet for this study

Summary

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Bilastine 40mg single dose

Single-dose only cohort treatment duration is 1 day. After the screening period, eligible subjects will be allocated to receive a single dose of 40 mg of bilastine

DRUG

Bilastine 20mg single-dose followed by multiple-dose

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.

Sponsors & Collaborators

  • A.Menarini Asia-Pacific Holdings Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Andrea Luk, Professor · Phase I Clinical Trial Centre, Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2019-04-30
Completion
2019-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633760 on ClinicalTrials.gov