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Effect of Delivery Route on PK of Sufentanil NanoTab

NCT01639729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-10-01

Study results available
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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

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)

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Principal Investigators

  • Pamela Palmer, M.D. · Talphera, Inc

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
2012-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

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 NCT01639729 on ClinicalTrials.gov