Status:
COMPLETED
Comparison of Naloxone Pharmacokinetics
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully...
Eligibility Criteria
Inclusion
- Males and females 18 to 55 years of age, inclusive
- Provide written informed consent
- BMI ranging from 18 to 32 kg/m2, inclusive
- Adequate venous access
- No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
- Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
- Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
- Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study
Exclusion
- Contact site directly for more information
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03386591
Start Date
January 3 2018
End Date
March 6 2018
Last Update
March 9 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212