Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents

Summary

The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to \<12 yrs and adolescents aged 12 to \<18 yrs.

Timeline

Start

2009-03-21

Primary completion

2009-04-26

Completion

2009-04-26

Publications

• Pathirana S, Jayawardena S, Meeves S, Thompson GA. Brompheniramine and Chlorpheniramine Pharmacokinetics Following Single-Dose Oral Administration in Children Aged 2 to 17 Years. J Clin Pharmacol. 2018 Apr;58(4):494-503. doi: 10.1002/jcph.1037. Epub 2017 Nov 14.

Drugs

Indications