Effect of Delivery Route on PK of Sufentanil NanoTab

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639729
• Other study ID #: IAP102
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2012
• Last updated: September 16, 2015
• Start date: July 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2015
• Source: AcelRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• body mass index 18 - 30

Exclusion Criteria:

• pregnant females

• smokers

• pulmonary disease

• sleep apnea

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	PRA	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (0 - Inf)	total amount of sufentanil absorbed	24 hours	No
Primary	Cmax	maximum plasma concentration	24 hours	No
Primary	Tmax	time to maximum plasma concentration	24 hours	No
Primary	CST 1/2	time for maximum plasma concentration to decrease by 50%	24 hours	No