None listed
Conditions
Interventions
The subjects will be treated with a single dose of loratadine syrup by mouth, and a blood sample will be taken at 12 h postdose.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: Pediatric subjects (aged> 2 to <12) of any race with atopic diseases such as allergic rhinitis, allergic asthma or atopic dermatitis, or a history of them, or with a personal history of UlC and who are therefore candidates to treatment with antihistamines or have been treated with antihistamines in the past.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of any clinically significant systemic or localized infectious disease within four weeks prior to the administration of treatment. 2. Subjects who have participated in a clinical trial of a drug in the research phase within 30 days prior to treatment, or who are participating in another clinical study. 3. Subjects with a clinically significant history of allergy to loratadine or desloratadine. 4. Subjects who have taken any other medication (prescribed or over-the-counter - except acetaminophen - within 14 days prior to treatment. 5. Subjects who have used a loratadine or desloratadine product within 30 days prior to treatment. 6. Subjects whose situation or state of health may interfere with their participation in the study according to the opinion of the researcher 7. Subjects that are family members of the personnel directly related to the study. 8. Subjects who have previously participated in this study (that is, who have signed the informed consent). 9. Women during the menstrual period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:plasma concentrations of DL and 3-OH DL Measure:plasma concentrations of DL and 3-OH DL after administration of loratadine syrup. Timepoints:12 hours of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Peru
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed