Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/13/2017 |
| Start Date: | October 2014 |
| End Date: | January 2015 |
Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg
dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose
that could achieve systemic exposure comparable to an approved parenteral dose. To also
determine the pharmacokinetics of two different concentrations of intranasal naloxone and
finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose
that could achieve systemic exposure comparable to an approved parenteral dose. To also
determine the pharmacokinetics of two different concentrations of intranasal naloxone and
finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
Inclusion Criteria:
- Be able to provide written consent
- Must have a BMI ranging from 18 to 30kg/m2, inclusive
- Must have adequate venous access
- Must not have any clinically significant concurrent medical conditions determine by
medical history, physical examination, vital signs, and 12-lead electrocardiogram.
- Must agree to use a reliable double-barrier method of birth control from the start of
screening until one week after completing the study. Oral contraceptives are
prohibited.
- Must agree to not ingest alcohol, drinks containing xanthine greater than 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 Criteria:
- Please contact clinical site directly for more information
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