At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Mucinex® SE +1 moredrug
Likely dose
Mucinex® SE 600 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.
A Phase I, Open-label, Single-dose, Randomized, 2-way Crossover Bioequivalence Study Comparing Mucinex® SE Extended-Release 600 mg Bi-layer Tablet to a Reference Immediate-Release Guaifenesin 600 mg (Taken as 200 mg q4h) in Normal Healthy Subjects.
In Brief
A Phase 1 clinical trial evaluating Mucinex® SE and Vicks Cough Syrup for Chesty Coughs for Healthy Subjects. Completed, enrolled 30 participants.
Detailed Summary
Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
Primary CompletionFeb 2009
First PostedAug 2018
TodayJul 2026
First PostedAug 23, 2018
Enrollment StartJan 16, 2009
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 15 daysPosted 7.9 years ago
Interventions
Mucinex® SEdrug
Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet
Vicks Cough Syrup for Chesty Coughsdrug
Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup