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Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics

NCT01721070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-11-04

Study results available
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Summary

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

Conditions

  • Pharmacokinetics

Interventions

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

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Principal Investigators

  • Pamela P. Palmer, MD, PhD · Talphera, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT01721070 on ClinicalTrials.gov