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

This is a single-center, randomized (study medication assigned to participants by chance),
open-label (all people know the identity of the intervention), single application and 2-way
Crossover (the same medications provided to all participants but in different sequence)
pivotal study to determine the bioequivalence of marketed reference formulation DURAGESIC and
the test formulation Fentanyl transdermal system (JNJ-35685-AAA-G021). Approximately 56
healthy participants will participate in this study. Participants will be randomly assigned
to 1 of 2 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21
days before the first study drug administration of the first period), an open-label treatment
Phase consisting of 2 single-application treatment periods (26 days) and End-of-Study (at the
end of Period 2). The total study duration for each participant will be from 43 days to a
maximum of 59 days. Participants will receive a single application 100 microgram per hour
(mcg/h) dose of DURAGESIC fentanyl transdermal system as Treatment A (Reference) and 100
mcg/h Fentanyl transdermal system (JNJ-35685-AAA-G021) as Treatment B (Test). Bioequivalence
will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be
monitored throughout the study.

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