Who is sponsoring NCT00399295?

NCT00399295 is sponsored by Alza Corporation, DE, USA.

What drugs are being tested in NCT00399295?

Interventions: Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg..

What is the status of NCT00399295?

NCT00399295 is currently COMPLETED.

Last reviewed 2010-04-26 · How we verify

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

NCT00399295 Phase 1 COMPLETED

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.

Details

Lead sponsor	Alza Corporation, DE, USA
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Completion	1997-06

Conditions

Analgesia

Interventions

Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg.

Primary outcomes

The primary endpoints for the statistical evaluations of the study drug were: Area Under the Concentration-Time Curve from 0 to Infinity and Peak Plasma Concentration.