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

NCT00398957 | Completed Phase 1

• 1 other identifier: CR011611
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Conditions

Analgesia

Keywords

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary endpoints were the pharmacokinetic parameters for the study drug: Time to Peak Plasma Concentration and Terminal half-life.

Interventions

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

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Publications (1)

• Sathyan G, Xu E, Thipphawong J, Gupta SK. Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone. BMC Clin Pharmacol. 2007 Feb 2;7:3. doi: 10.1186/1472-6904-7-3.

  PMID: 17270058 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2006
• First Posted: November 14, 2006
• Study Completion: September 1, 1998
• Last Updated: April 27, 2010

Record last verified: 2010-04