Conditions: Healthy Volunteers
Keywords: Healthy subjects Opioid
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 88
Healthy volunteers: yes

Brief summary:
To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed 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 40 mg x 1 dose arm 2: Original OxyContin® (OXY) 40 mg x 1 dose

Interventions: intervention 1: Reformulated OXY (oxycodone HCl) intervention 2: Original OxyContin® (OXY) (oxycodone HCl)
Intervention descriptions: intervention 1: Reformulated OXY 40-mg tablet x 1 dose taken with food intervention 2: Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food

Protocol document: