NCT01639729

Effect of Delivery Route on PK of Sufentanil NanoTab

Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Treatment A: Sufentanil IV	Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
DRUG	Treatment B: Sufentanil NanoTab Sublingual	Single Sufentanil NanoTab 15 mcg given sublingually (SL)
DRUG	Treatment C: Sufentanil NanoTab Buccal	Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
DRUG	Treatment D: Sufentanil NanoTab Oral	Single Sufentanil NanoTab 15 mcg swallowed (PO)

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-07-13
• Last updated: 2015-10-01
• Results posted: 2014-05-21

Locations

1 site across 1 country: United States