Status:
COMPLETED
An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Analgesia
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
The primary objective of this study was to examine the OROS® Hydromorphone HCL pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile for dose proportionality afte...
Detailed Description
This was a randomized (patients are assigned different treatments based on chance), open-label, four-way crossover study performed in normal, healthy adult patients. Each patient received the followin...
Eligibility Criteria
Inclusion
- Patients were non-smoking, healthy volunteers with body weight between 135 and 220 pounds and within +/- 10% of their recommended weight range for their height and body frame according to the Metropolitan Height and Weight Tables
- Patients had a negative baseline urine screen for drugs of abuse
- Patients did not have any clinically significant deviations from normal in any laboratory test value.
Exclusion
- Patients intolerant of or hypersensitive to hydromorphone or naltrexone
- Patient with any gastrointestinal disorder that may affect the absorption of orally administered drugs
- Patients with depressed respiratory function
- Patient with impaired renal or hepatic function
- Patient with dependence to opiates
- pregnant or breast feeding
- Female patients of child bearing potential must have a negative pregnancy test each week prior to administration of study drug and required to be following a medically rhydromorphoneadministrationnaltrexone recognized contraceptive program prior to and during the study.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1998
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00398957
End Date
September 1 1998
Last Update
April 27 2010
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