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

• Status: Completed
• Trial end date: 1997-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Hydromorphone; Naltrexone; Narcotic Antagonists

Criteria

Inclusion Criteria:

• Patients were non-smoking, healthy volunteers with body weights between 135 and 220 pounds and within + - 10% of their recommended weight range for their height and body frame according to the 1984 Metropolitan Height and Weight Tables

• A negative baseline urine drug screen for cannabinoids, opiates, cocaine, ethanol and barbiturates.

Exclusion Criteria:

• Patients intolerant of or hypersensitive to hydromorphone or naltrexone

• Patients with any gastrointestinal disorder that may affect the absorption of orally administered drugs

• Patient with depressed respiratory function

• Patient with impaired renal or hepatic function

• Patients with dependence to opiates

• Pregnant or breast feeding

• Female Patients of childbearing potential must have a negative pregnancy test each week prior to administration of study drug and required to be following a medically recognized contraceptive program prior to and during the study.