At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Children's Mucinex® Grape Flavor +1 moredrug
Likely dose
Children's Mucinex® Grape Flavor 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating Children's Mucinex® Grape Flavor for Healthy Subjects. Completed, enrolled 24 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
Primary CompletionJul 2011
First PostedAug 2018
TodayJul 2026
First PostedAug 16, 2018
Enrollment StartJun 18, 2011
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 13 daysPosted 7.9 years ago
Interventions
Children's Mucinex® Grape Flavordrug
1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
Children's Mucinex® Grape Flavordrug
1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation