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 - Full Text View

Sponsored by:	Alza Corporation, DE, USA
Information provided by:	Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:	NCT00399295

Purpose

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.

Condition	Intervention	Phase
Analgesia	Drug: Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg.	Phase I

Drug Information available for: Naltrexone Naltrexone hydrochloride Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Official Title:	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

Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Secondary endpoints were the parameters for the study drug: Area Under the Concentration-Time Curve from 0 to Time t, Time to Peak Plasma Concentration and Terminal Half Life).

Estimated Enrollment:	30
Study Completion Date:	June 1997

Detailed Description:

This was a randomized (patients are assigned different treatments based on chance), open-label, three-way crossover study, performed in normal, healthy adults. Each patient received orally administered treatments (a different treatment during each dosing phase): Treatment A: single dose of Dilaudid SR 16 mg administered under fasting conditions without the naltrexone block;Treatment B: single dose of Dilaudid SR 16 mg administered under fed conditions without the naltrexone block, Treatment C: single dose of Dilaudid SR 16 mg administered under fasting conditions with naltrexone HCL 50mg block (3 oral doses of 50mg each administered 12 hours prior to , at the time of, and 12 hours after Dilaudid SR 16mg administration). There was a 7-day washout period between dosing phases. Venous blood sampling times were 0 (prior to dosing),2,4,6,8,10,12,16,20,24,30,36,42,and 48 hours after each Dilaudid SR administration. LC/MS/MS (Liquid Chromatography/Mass Spectroscopy/Mass Spectroscopy)techniques were employed for the analysis of plasma for hydromorphone concentration.

Each patient randomly received orally-administered treatments of single dose of Dilaudid SR 16mg; under fasting conditions without the naltrexone block; under fed conditions without naltrexone block; under fasting conditions with naltrexone 50mg block (3 oral doses of 50mg naltrexone HCL each administered 12 hours prior to, at the time of, and 12 hours after hydromorphone administration); 7-day washout period between dosing phases.

Eligibility

Ages Eligible for Study:	19 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399295

Sponsors and Collaborators

Alza Corporation, DE, USA

Investigators

Study Director:

Alza Corporation Clinical Trial

Alza Corporation, DE, USA

More Information

No publications provided by Alza Corporation, DE, USA

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	CR011608
Study First Received:	November 10, 2006
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00399295 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:

Analgesia

Study placed in the following topic categories:

Hydromorphone
Narcotic Antagonists
Naltrexone
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Hydromorphone
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Sensory System Agents

Therapeutic Uses
Naltrexone
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009