Biological Availability Clinical Trial
Official title:
Pharmacokinetics of Naltrexone Hydrochloride (HCl) Following Intravenous (i.v.) and Oral Routes of Administration in Healthy Subjects
The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of naltrexone following oral administration. Moreover, safety is assessed.
Naltrexone blocks the effects of opioid (morphine-like) drugs by competitive binding at the
opioid receptors in the brain. Naltrexone does not possess morphine-like properties and
exhibits minimal pharmacologic activity. Naltrexone is marketed as an oral tablet. A wide
range of oral bioavailability values have been reported for naltrexone. The wide range in
oral bioavailability of naltrexone appears to be due to differences in assay specificity and
the method of estimation of bioavailability (use of total drug, free drug, or urinary
excretion data rather than plasma level). This was a single-center, randomized (study drug
assigned by chance), open-label, 2-treatment, 2-period crossover study in healthy
volunteers. Healthy volunteers were randomly assigned to 1 of 2 treatment sequences (AB or
BA) with a washout period of 6 to 14 days between treatments. The washout period commenced
the day of dosing, after drug administration. Blood samples for determination of blood
naltrexone levels were collected at scheduled time points from the arm opposite to the 1
selected for naltrexone i.v. administration. Pulse, blood pressure, breathing rate, body
temperature were measured at the times listed in the study schema. Healthy volunteers
remained at the research facility for blood sample collection periods and were monitored for
adverse events throughout the treatment periods.
Treatment A: 1 mg naltrexone HCl administered i.v. over 15 minutes (naltrexone i.v.).
Treatment B: 50 mg naltrexone HCl administered orally (naltrexone oral).
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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