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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

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Treatment A: DUROGESIC (8.4 mg fentanyl) (Drug); Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl) (Drug); Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl) (Drug); Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl) (Drug); Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

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.

Clinical Details

Official title: An Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 4 New Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Fentanyl serum concentrations

Determination of residual fentanyl content in the worn patchs

The skin adherence score of the patches

Secondary outcome: The incidence of adverse events

Detailed description: This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), 4-way crossover (participants will receive different interventions sequentially during the trial) study. The study will assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of 4 new formulations of fentanyl transdermal patch, TDS-Concept 1 50 µg/h, TDS-Concept 2 50 µg/h, TDS-Concept 3 50 µg/h and TDS-Concept 4 100 µg/h compared with DUROGESIC fentanyl 50 µg/h in healthy participants after a single application. All participants will be randomly assigned to 1 of 8 possible treatment sequences. During the 4 single-application treatment periods, each transdermal patch will be worn, on a different application site on the lateral side of the upper arm, continuously for 72 hours. The treatment periods will be separated by a washout period (period when receiving no treatment) of at least 8 and no more than 14 days. The total study length is from 64 days to a maximum of 82 days.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Antwerp, Belgium
Additional Information

Starting date: August 2012
Last updated: March 5, 2014

Page last updated: August 23, 2015

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