Conditions: Pharmacokinetics
Keywords: pharmacokinetics area under curve time to maximum concentration
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief summary:
Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Detailed description:

Arms:
arm 1: 15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral arm 2: 15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal arm 3: 15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral arm 4: 15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual arm 5: 15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal arm 6: 15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual

Interventions: intervention 1: Treatment A: Sufentanil IV intervention 2: Treatment B: Sufentanil NanoTab Sublingual intervention 3: Treatment C: Sufentanil NanoTab Buccal intervention 4: Treatment D: Sufentanil NanoTab Oral
Intervention descriptions: intervention 1: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) intervention 2: Single Sufentanil NanoTab 15 mcg given sublingually (SL) intervention 3: Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) intervention 4: Single Sufentanil NanoTab 15 mcg swallowed (PO)

Protocol document: