NCT01721070

Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Pharmacokinetics

Interventions

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

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-11-05
• Last updated: 2016-11-04
• Results posted: 2014-03-26

Locations

1 site across 1 country: United States