Status:
COMPLETED
Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of OROS Hydromorphone in healthy adult Taiwanese participants after oral administration of 4 different dose strengths of 8, 16, 32 and 64 ...
Detailed Description
This is a single-center, randomized (study drug assigned by chance like flipping a coin), open-label (all people involved know the identity of the intervention), 4-way crossover (participants receive ...
Eligibility Criteria
Inclusion
- 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 :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01487512
Start Date
March 1 2011
End Date
July 1 2011
Last Update
November 16 2012
Active Locations (1)
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1
Taipei, Taiwan