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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

Page last updated: August 23, 2015

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