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A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer

NCT01824524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-08-15

No results posted yet for this study

Summary

The purpose of this study is to assess the single dose pharmacokinetic profile (explores what a drug does to the body) and safety of Osmotic Release Oral System (OROS) hydromorphone in chinese participants with cancer (abnormal tissue that grows and spreads in the body) who are not opioid (morphine-like medications) tolerant (decrease in response to a fixed dosage of drug over time and higher doses of a drug are needed to get desired effect).

Conditions

Interventions

DRUG

Hydromorphone

Participants will be administered a single dose of Osmotic Release Oral System (OROS) hydromorphone tablet of 8 milligram (mg) orally on Day 1 under fasting conditions.

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd. Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824524 on ClinicalTrials.gov