NCT03642262

Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Reckitt Benckiser Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Mucinex®	Mucinex® 600 mg single dose ER bi-layer tablet

Timeline

• Start date: 2013-06-02
• Primary completion: 2013-08-09
• Completion: 2013-08-09
• First posted: 2018-08-22
• Last updated: 2019-06-17
• Results posted: 2019-06-17

Regulatory

• FDA-regulated drug study