The study will characterize the single-dose pharmacokinetics of naltrexone and metabolite (6 Beta-naltrexol) following administration of SP-104 compared to Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects under fasting conditions. The study will also characterize the effect of food intake on the pharmacokinetics of SP-104 in healthy adult subjects. Additionally, the safety and tolerability of single doses of SP-104 under fed and fasting conditions will be characterized.
This open-label, 3-period, 3-treatment, randomized study will characterize the pharmacokinetics and safety and tolerability of SP-104 under fasting and fed conditions as compared to the pharmacokinetics of Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects.