Conditions: Pharmacokinetics
Keywords: Area under curve, time to maximum concentration
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 19
Healthy volunteers: yes

Brief summary:
Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.

Detailed description:

Arms:
arm 1: Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil. arm 2: Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose.

Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.

Interventions: intervention 1: Sufentanil NanoTab (SUF NT) 15 mcg intervention 2: Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg
Intervention descriptions: intervention 1: Period 1: One dose of SUF NT 15 mcg administered sublingually intervention 2: Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day

Protocol document: