NCT03644095

Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Reckitt Benckiser Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Mucinex® SE	Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet
DRUG	Vicks Cough Syrup for Chesty Coughs	Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup

Timeline

• Start date: 2009-01-16
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2018-08-23
• Last updated: 2019-06-19
• Results posted: 2019-06-19

Regulatory

• FDA-regulated drug study