Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
NCT ID: NCT01721070
Last Updated: 2016-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2012-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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SUF NT 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
Sufentanil NanoTab (SUF NT) 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually
Ketoconazole 400 mg, SUF NT 15 mcg
Ketoconazole 400 mg administered once daily for three days. One dose of SUF NT 15 mcg was co-administered sublingually with the third (last) ketoconazole dose.
Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
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
Interventions
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Sufentanil NanoTab (SUF NT) 15 mcg
Period 1: One dose of SUF NT 15 mcg administered sublingually
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
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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Pamela P. Palmer, MD, PhD
Role: STUDY_DIRECTOR
Talphera, Inc
Locations
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PRA
Lenexa, Kansas, United States
Countries
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Other Identifiers
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IAP104
Identifier Type: -
Identifier Source: org_study_id