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
Information source: Alza Corporation, DE, USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Analgesia
Intervention: Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg. (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Primary outcome: 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: 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).
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
Minimum age: 19 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Ending date: June 1997
Last updated: April 17, 2008
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