A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples o… (NCT02608320) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants
United States52 participantsStarted 2015-11-17
Plain-language summary
The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
* 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 specified in this protocol
* Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive, and a body weight of not less than 50 kg
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, inclu…
What they're measuring
1
Cumulative Adhesion Percentage
Timeframe: Time of patch application up to patch removal (up to 72 hours)