A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers
NCT ID: NCT03827642
Last Updated: 2019-02-01
Study Results
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Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2018-04-23
2018-05-06
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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Cohort 1: Treatment Sequence A-D-C-B
Participants received Treatment A on Day 1 of Period 1, Treatment D on Day 1 of Period 2, Treatment C on Day 1 of Period 3 and Treatment B on Day 1 of Period 4.
Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Cohort 2: Treatment Sequence B-C-D-A
Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, Treatment D on Day 1 of Period 3 and Treatment A on Day 1 of Period 4.
Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Cohort 3: Treatment Sequence C-A-B-D
Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, Treatment B on Day 1 of Period 3 and Treatment D on Day 1 of Period 4.
Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Cohort 4: Treatment Sequence D-B-A-C
Participants received Treatment D on Day 1 of Period 1, Treatment B on Day 1 of Period 2, Treatment A on Day 1 of Period 3 and Treatment C on Day 1 of Period 4.
Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Interventions
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Treatment A: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment B: Naloxone Nasal Spray
Participants received naloxone nasal spray following a 10 hour fast.
Treatment C: Naloxone HCl Intravenous (IV) Injection
Participants received naloxone HCl IV injection following a 10 hour fast.
Treatment D: Naloxone HCl Intramuscular (IM) Injection
Participants received naloxone HCl IM injection following a 10 hour fast.
Eligibility Criteria
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Inclusion Criteria
* A seated blood pressure between 90 and 140 mmHg systolic/50 and 90 mmHg diastolic
* Female subjects had a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test at screening
Exclusion Criteria
* Any documented clinically significant infection, injury, or illness within 1 month prior to screening
* An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening
* A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening
* A positive urine test result for alcohol, drugs, or cotinine at screening or check-in
* A condition that the investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk
* Used any opioids for 30 days prior to Day 1
* Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
* Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestions
18 Years
45 Years
ALL
Yes
Sponsors
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INSYS Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni DeCastro
Role: STUDY_DIRECTOR
INSYS Therapeutics Inc
Locations
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Worldwide Clinical Trials
San Antonio, Texas, United States
Countries
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Other Identifiers
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INS012-18-119
Identifier Type: -
Identifier Source: org_study_id
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