Conditions: Healthy Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects.

Detailed description:

Arms:
arm 1: Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions. arm 2: Hydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state. arm 3: Hydrocodone Bitartrate 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals and guaifenesin (Humibid®) 1200 mg ER administered with 240 mL of room temperature water in the fasted state.

Interventions: intervention 1: Humibid® intervention 2: Hydrocodone Bitartrate intervention 3: Humibid® and Hydrocodone Bitartrate tablet
Intervention descriptions: intervention 1: Humibid® 1200 mg (single extended release) tablet intervention 2: Hydrocodone Bitartrate (3.33 mg q4h X 3) intervention 3: Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)

Protocol document: