NCT01487512

Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Treatment A: Hydromorphone 8 mg	type= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences.
DRUG	Treatment B: Hydromorphone 16 mg	type= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences.
DRUG	Treatment C: Hydromorphone 32 mg	type= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences.
DRUG	Treatment D: Hydromorphone 64 mg	type= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-12-07
• Last updated: 2012-11-16

Locations

1 site across 1 country: Taiwan