NCT02082236

Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Treatment Arm A: Sufenta®	Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute
DRUG	Treatment B: Sufentanil SSM 30 mcg	single-dose SSM 30 mcg
DRUG	Treatment C: SSM 15 mcg	2 consecutive doses of SSM 15 mcg administered 20 minutes apart
DRUG	Treatment D: SSM 30 mcg	12 consecutive doses of SSM 30 mcg administered 1 hour apart

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-03-10
• Last updated: 2018-07-17

Locations

1 site across 1 country: United States