Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the pharmacokinetics of OROS hydromorphone in healthy adult Taiwanese participants after the oral administration of a single 16 mg dose.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• Participation in the DNA analysis to confirm UGT2B7 genotype status

• Body mass index (BMI) between 18 and 25 kg/m², inclusive and a body weight of not less than 50 kg

• Participants must utilize a medically acceptable method of contraception throughout the entire study period and for 1 month after the study is completed

• Each participant will receive a naloxone challenge test for opioid dependency at screening. Only those participants who pass this challenge test will be allowed to continue in the study

Exclusion Criteria:

• History of or current clinically medical illness or any other condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis

• Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG)

• Use of certain prescription or nonprescription medication, and consumption of products that may interfere with the study