Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
NCT ID: NCT02474407
Last Updated: 2018-10-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
78 participants
INTERVENTIONAL
2015-06-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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diazepam nasal spray (DZNS)
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
diazepam rectal gel (DRG)
A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.
diazepam rectal gel
Interventions
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diazepam nasal spray
diazepam rectal gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body weight 26 to 111 kilogram (kg) inclusive
Exclusion Criteria
* Female subject who is pregnant, breastfeeding, or planning to become pregnant
* Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
12 Years
65 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Lee Min Jae
Role: STUDY_DIRECTOR
SK Biopharmaceuticals Co, Ltd
Locations
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Acorda Site #115
Little Rock, Arkansas, United States
Acorda Site #127
Washington D.C., District of Columbia, United States
Acorda Site #101
Tampa, Florida, United States
Acorda Site #125
Honolulu, Hawaii, United States
Acorda Site #104
Lexington, Kentucky, United States
Acorda Site #111
Baltimore, Maryland, United States
Acorda Site #102
Bethesda, Maryland, United States
Acorda Site #110
Ann Arbor, Michigan, United States
Acorda Site #117
Jackson, Mississippi, United States
Acorda Site #112
St Louis, Missouri, United States
Acorda Site #128
Edison, New Jersey, United States
Acorda Site #121
Hackensack, New Jersey, United States
Acorda Site #123
Amherst, New York, United States
Acorda Site #119
Rochester, New York, United States
Acorda Site #132
Chapel Hill, North Carolina, United States
Acorda Site #114
Portland, Oregon, United States
Acorda Site #116
Philadelphia, Pennsylvania, United States
Acorda Site #105
Philadelphia, Pennsylvania, United States
Acorda Site #130
Memphis, Tennessee, United States
Acorda Site #103
Bellaire, Texas, United States
Acorda Site #122
Dallas, Texas, United States
Acorda Site #108
Houston, Texas, United States
Countries
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Other Identifiers
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DZNS-EP-1019
Identifier Type: -
Identifier Source: org_study_id
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