An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: All

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 after administration of 8mg, 16mg, 32mg and 64 mg tablets.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Hydromorphone; Naltrexone; Narcotic Antagonists

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.