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

NCT02082236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Principal Investigators

  • Sandra K. Willsie, D.O. · PRA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02082236 on ClinicalTrials.gov