Healthy Thai volunteers Healthy Thai volunteers
Conditions
Interventions
Bilaxten, Bilastine 20 mg product of A.Menarini. Italy,Bilaz, Bilastine 20 mg product of Macrophar Co Thailand
Active Comparator Drug,Experimental Drug
Sponsors
Macrophar Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Healthy Thai male or female subjects between the ages of 18 to 55 years. Body mass index between 18.5 to 30.0 kg/m2. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: History of allergic reaction or hypersensitivity to bilastine or to any of the excipients. History or evidence of clinically significant or any significant ongoing chronic medical illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours post-dose. standard non-compartmental methods | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC 0-t 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hours post-dose. standard non-compartmental methods | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co., Ltd.
Outcome results
None listed