Conditions: Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief 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

Detailed description:

Arms:
arm 1: Mucinex® ER 600 mg bi-layer single dose tablet by mouth under fasting condition. arm 2: Guaifenesin 200 mg immediate release (IR) tablet thrice (at 0, 4, and 8 hours) by mouth under fasting condition.

Interventions: intervention 1: Mucinex®
Intervention descriptions: intervention 1: Mucinex® 600 mg single dose ER bi-layer tablet

Protocol document: