Status:
COMPLETED
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
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Analgesia
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief 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)...
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 administere...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1997
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00399295
End Date
June 1 1997
Last Update
April 27 2010
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