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

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: OROS® Hydromorphone HCL; OROS® Dilaudid; Dilaudid SR (slow release); Naltrexone (an opioid antagonist). (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 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.

Clinical Details

Official title: An Open Label Evaluation of the Dose Proportionality of Dilaudid SR (OROS Hydromorphone HCL) Tablets 8mg, 16mg, 32mg, and 64mg

Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics 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, Area Under the Concentration-Time Curve from 0 to time t and Peak Plasma Concentration.

Secondary outcome: The secondary endpoints were the pharmacokinetic parameters for the study drug: 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, four-way crossover study performed in normal, healthy adult patients. Each patient received the following orally administered treatments of OROS Hydromorphone HCL (a different treatment during each dosing phase): Treatment A: 8mg; Treatment B: 16mg; Treatment C: 32mg; Treatment D: 64mg; A naltrexone 50mg dose was administered 12 hours prior to, at the time of, and 12 after study drug administration; Patients received a fourth dose of naltrexone 50mg 24 hours after the 64mg study drug administration. There was a 7-day washout period between study drug 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 study drug administration. Three additional blood samples (at 56, 64, and 72 hours after dosing of study drug) were drawn from those patients receiving the 64 mg tablets; LC/MS/MS (Liquid Chromatography/Mass Spectroscopy/Mass Spectroscopy) techniques were employed for the analysis of plasma hydromorphone concentrations. The primary endpoints of interest were: Area under the concentration-time curve from zero to infinity; Area under the concentration-time curve from zero to time t; Peak plasma concentration; the secondary endpoint parameters were: Time to peak plasma concentration; Terminal half-life.

OROS hydromorphone HCL tablets of 8mg, 16mg, 32mg, and 64mg were given orally, a different dosing treatment during each dosing phase. One naltrexone HCL 50mg tablet was given orally 12 hours prior to, at the time of, and 12 hours after hydromorphone administration during each dosing phase. Patient received a fourth dose of naltrexone 50mg 24 hours following the 64mg study drug adminstration; It was a four week treatment and there was a seven-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 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

Locations and Contacts

Additional Information


Ending date: September 1998
Last updated: April 17, 2008

Page last updated: June 20, 2008

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