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

Brief 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.

Detailed description:

Arms:
arm 1: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet taken with 240 mL of water after an overnight fast arm 2: Vicks Cough Syrup for Chesty Coughs 200 mg every 4 hours taken with 240 mL of water after an overnight fast

Interventions: intervention 1: Mucinex® SE intervention 2: Vicks Cough Syrup for Chesty Coughs
Intervention descriptions: intervention 1: Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet intervention 2: Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup

Protocol document: