NCT03633448

Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents

An Open-label, Single-dose, Randomized, Two-way Crossover Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents at Immediate-release Doses of 200 mg and 400 mg.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Reckitt Benckiser LLC · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Evaluate the pharmacokinetics (PK), Safety and tolerability of guaifenesin (Mucinex®) in an immediate-release formulation when a single dose is administered in adolescents and in adults when compared to Children.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Children's Mucinex® Grape Flavor	1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
DRUG	Children's Mucinex® Grape Flavor	1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation

Timeline

• Start date: 2011-06-18
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2018-08-16
• Last updated: 2019-06-17
• Results posted: 2019-06-17

Regulatory

• FDA-regulated drug study