Abstract:
STUDY OBJECTIVE:To evaluate the pharmacokinetics and dose-proportionality of four dose strengths (5, 10, 20, and 40 mg) of oxymorphone extended release (ER) under both single-dose and steady-state conditions. DESIGN:Randomized, three-period, four-sequence, crossover study. SETTING:Bioavailability clinic. SUBJECTS:Twenty-four healthy adult volunteers. INTERVENTION:Each subject received three of the four possible doses. The three 8-day administration periods were separated by a 7-day washout. Plasma was collected for up to 48 hours after a single dose on day 1 and during a 12-hour dosage interval at steady state. Naltrexone was administered to reduce opioid-related adverse effects. MEASUREMENTS AND MAIN RESULTS:Twenty-three subjects completed at least one study period. Dose-proportionality and linearity were confirmed after single doses (mean oxymorphone ER area under the concentration versus time curve [AUC] 4.54, 8.94, 17.80, and 37.90 ng x hr/ml for 5-, 10-, 20-, and 40-mg doses, respectively) and at steady state (mean oxymorphone ER AUC 5.60, 9.77, 19.3, and 37.0 ng x hr/ml for 5-, 10-, 20-, and 40-mg doses every 12 hrs, respectively). Similar results were found for maximum plasma concentration. Metabolite (6-hydroxyoxymorphone and oxymorphone-3-glucuronide) plasma levels also increased in a linear fashion after single-dose administration and at steady state. CONCLUSION:The pharmacokinetic profile of oxymorphone ER demonstrates linearity and dose-proportionality under single-dose and steady-state conditions for the parent compound and its metabolites for doses of 5-40 mg.
journal_name
Pharmacotherapyjournal_title
Pharmacotherapyauthors
Adams MP,Ahdieh Hdoi
10.1592/phco.24.5.468.33347subject
Has Abstractpub_date
2004-04-01 00:00:00pages
468-76issue
4eissn
0277-0008issn
1875-9114journal_volume
24pub_type
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