A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg

• Participants must utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 3 months (men) or 1 week (women) after the study is completed

• Men must not donate sperm from the first drug administration until 3 months after completion of the study

• Each participant will receive a test for opioid dependency. Only those participants that pass this challenge test will be allowed to continue in this study

• Non-smoker

Exclusion Criteria:

• History of or current clinically significant medical illness, disease or condition that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results

• Clinically significant abnormal laboratorial values

• Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled

• History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years