Status:
COMPLETED
Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is a single-center, open-label (all people know the identity of the intervention), single-dose study in healthy adult Taiwanese participants. A minimum of 6 participants identified as having the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01487564
Start Date
October 1 2011
End Date
January 1 2012
Last Update
March 4 2013
Active Locations (1)
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1
Taipei, Taiwan