Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.

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

Details

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

Criteria

Inclusion Criteria:

• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. This determination must be recorded in the participant's source documents and initialed by the investigator

• Not of childbearing potential: postmenopausal [greater than (>) 45 years of age with amenorrhea for at least 12 months; permanently sterilized (example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy

• Of childbearing potential and practicing a reliable method of birth control, throughout the study and for 1 week after the study is completed. The method must be consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); double-barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant)

• A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at Screening and urine pregnancy test at Day -1 of the first treatment period

• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study

• Participant must be willing and able to adhere to the prohibitions and restrictions as specified in the protocol

Exclusion Criteria:

• Participant has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency [(creatinine clearance below 60 milliliter per minute (mL/min)]; thyroid disease; neurologic or psychiatric disease; infection; or any other illness 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 at Screening as deemed appropriate by the investigator

• Clinically significant abnormal physical examination, vital signs or 12 lead ECG at Screening as deemed appropriate by the investigator

• Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product [example, antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy]. Throughout the study, prescription or nonprescription medication (including vitamins and herbal supplements) other than the study drugs [Fentanyl Transdermal Therapeutic System (TTS), Naloxone and Naltrexone] are prohibited, except for acetaminophen and hormonal contraceptives by women participants. The use of acetaminophen is allowed until 3 days before each study drug administration. Throughout the study, a maximum of 3 doses per day of 325 milligram (mg) acetaminophen, and no more than 3 gram (g) during the time of confinement of each dosing period will be allowed for the treatment of headache or other pain

• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens (phencyclidine, psilocybin, and d-lysergic acid diethylamide [LSD]), or barbiturates at Screening