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Study to Evaluate the Pharmacokinetics of Guaifenesin in Adults and Adolescents

NCT03633448 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-06-17

Study results available
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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

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

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-18
Primary Completion
2011-07-01
Completion
2011-07-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633448 on ClinicalTrials.gov