Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Treatment A: Hydromorphone 8 mg (Drug); Treatment B: Hydromorphone 16 mg (Drug); Treatment C: Hydromorphone 32 mg (Drug); Treatment D: Hydromorphone 64 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 mg under fasted conditions.
Clinical Details
Official title: A Single-Dose, Open-Label, Randomized, Crossover Dose Proportionality Study to Evaluate the Effect of Dose on the Pharmacokinetics of 8, 16, 32 and 64 mg OROS Hydromorphone Under Fasted Conditions in Healthy Adult Taiwanese Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma hydromorphone concentrations
Secondary outcome: Number of participants with adverse events as a measure of safety and tolerability
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 different interventions sequentially during the trial) study in
healthy adult Taiwanese participants. All participants will be randomly assigned to 1 of the
4 different possible treatment sequences and will receive all treatments in the order
specified by the randomization schedule. The study consists of a screening phase, an
open-label treatment phase consisting of 4 single-dose treatment periods, and end-of-study
or withdrawal assessments. During the open-label treatment periods, the participants will
stay in the center until completion of the 72-hour pharmacokinetics [PK] (how the drug is
absorbed in the body, distributed within the body, and how it is removed from the body over
time) blood sample on Day 4. A 7- to 14-day washout period (period when receiving no
treatment) will separate the open-label treatment periods. The safety and tolerability will
be evaluated over the investigated dose range. The duration of participation in the study
for an individual participant will be approximately 12 weeks.
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: - 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
Locations and Contacts
Taipei, Taiwan
Additional Information
Starting date: March 2011
Last updated: November 15, 2012
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