An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg

Phase 1 Completed 30 enrolled Alza Corporation

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study was to compare the pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic profile of Dilaudid SR.

Timeline

Start: —
Primary completion: —
Completion: 1997-06

Publications

Sathyan G, Xu E, Thipphawong J, Gupta SK. Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence and absence of food. BMC Clin Pharmacol. 2007 Feb 2;7:2. doi: 10.1186/1472-6904-7-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydromorphone	Other / unclassified	16 mg	—
Subject	Naltrexone	Small molecule	50 mg	—

Indications

No indication recorded.