Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
NCT ID: NCT01761565
Last Updated: 2015-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2013-01-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg
Period 1: Single dose of SUF NT 15 mcg
Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Single dose of SUF NT 15 mcg
40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Interventions
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Single dose of SUF NT 15 mcg
40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 18 to 45 year, inclusive
* BMI between 18 and 30
Exclusion Criteria
* Pregnant females
* Subjects with pulmonary disease or sleep apnea
18 Years
45 Years
ALL
Yes
Sponsors
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Talphera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sandra K. Willsie, D.O.
Role: PRINCIPAL_INVESTIGATOR
PRA
Locations
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PRA
Lenexa, Kansas, United States
Countries
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References
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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.
Other Identifiers
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IAP101
Identifier Type: -
Identifier Source: org_study_id
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