Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents

Allergic Reactions Clinical Trial

Official title: A Single-Dose, Open-Label, Pharmacokinetic Study of Chlorpheniramine Maleate Liquid in Children and Adolescents

Status Completed

Clinical Trial Summary

The purpose of this study is to examine the pharmacokinetic parameters of chlorpheniramine in children and adolescents.

Clinical Trial Description

This is a single-group, single-center, open-label, one period, bioavailability study. This study will evaluate the pharmacokinetic (PK) profile of chlorpheniramine in a population of children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs. Twelve blood samples (3.0 mL) for chlorpheniramine analysis will be drawn at time 0 (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours after dosing. Plasma levels of chlorpheniramine will be determined. The following primary, single-dose PK parameters for chlorpheniramine will be determined using noncompartmental methods: AUCL, AUCI, and Cmax. The following PK parameters will also be determined to provide a complete profile of the drug, as appropriate: oral clearance (CL) and volume of distribution (Vd) and adjusted for body weight (per kg); time to reach Cmax (tmax), and apparent elimination constant (Kel) and half-life (t1/2). The PK parameters will be summarized using descriptive statistics. ;

Related Conditions & MeSH terms

• Allergic Reactions
• Hypersensitivity

• NCT number: NCT00837837
• Study type: Interventional
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Status: Completed
• Phase: Phase 1
• Start date: December 21, 2008
• Completion date: February 2, 2009