At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Mucinex®drug
Likely dose
Mucinex® 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® Extended Release 600 mg Bi-Layer Tablet to a Reference Immediate Release Guaifenesin Tablet (Taken as 200 mg Every 4 Hours [q4h] x 3 Doses) in Normal Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Mucinex® for Healthy Subjects. Completed, enrolled 30 participants.
Detailed Summary
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
Primary CompletionAug 2013
First PostedAug 2018
TodayJul 2026
First PostedAug 22, 2018
Enrollment StartJun 2, 2013
Primary CompletionAug 9, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.9 years ago
Interventions
Mucinex®drug
Mucinex® 600 mg single dose ER bi-layer tablet