Allergic Disease, Children
Conditions
Brief summary
To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.
Interventions
OTHER1-3 Cetirizine Pharmacokinetic samples
Limited sampling strategy was used in this study. For each child, only 1\ 3 blood samples were collected before and after cetirizine administration.
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form). 2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy. 3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis. 4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.
Exclusion criteria
1. Abnormal liver function (ALT or AST \> 2 times the upper limit of normal). 2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR \< 10 mL/min) 3. Electrolyte abnormalities (potassium or magnesium \< 0.8 times lower limit of normal, \> 1.2 times upper limit of normal) 4. Children who were allergic to cetirizine or had a history of serious adverse reactions. 5. Pediatric patients with unstable vital signs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration | 0.5 ~ 48 hours before and after administration |
Countries
China
Contacts
Primary ContactDongyang Liu
Backup ContactYafen Li
Outcome results
None listed