Conditions: Healthy
Keywords: Healthy subjects Opioid Healthy volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 58
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.

Detailed description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

Arms:
arm 1: Reformulated OXY 80 mg (Totowa) x 1 dose arm 2: Reformulated OXY 80 mg (Wilson) x 1 dose

Interventions: intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food. intervention 2: Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.

Protocol document: