Trials / Completed
CompletedNCT00894634
Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents
A Single-Dose, Open-Label, Pharmacokinetic Study of Brompheniramine Maleate Liquid in Children and Adolescents
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brompheniramine maleate |
Timeline
- Start date
- 2009-03-21
- Primary completion
- 2009-04-26
- Completion
- 2009-04-26
- First posted
- 2009-05-07
- Last updated
- 2020-10-23
Source: ClinicalTrials.gov record NCT00894634. Inclusion in this directory is not an endorsement.