Study Details

Study Purpose

The purpose of this study is to see if the test product (investigational drug) is the same as the reference product (the approved version of the drug) by measuring the adhesive properties (how well the study patches stick to the skin). This study will also monitor the safety of these products.

Study Duration

After screening, the expected study duration will be approximately 21 days with each period of the study will last approximately 8 days from the start of confinement to the removal of the TDS. There will be a 7-day “rest period” between two treatments in which a patch will also be provided to you and placed on your shoulder.

• Screening Visit (Day -35 to Day -1): (about 3 hours-but may vary)
• Check-in Visit (Day -1) of Periods 1 and (Day 14) of period 2: Pre-Dosing Overnight Stay
• Dosing Day (Day 1 to Day 7) of Treatment Period 1 and Day (15 to 21) of Treatment Period 2: Confinement Period
• At 168 hours (Day 8 of period 1) and (Day 22 of period 2) after study drug application
• Rest Period (Non-Confinement) (Day 8 to Day 14)

General Screening

NA

Medical Screening

Contact recruitment

Study Visit(s)

Contact recruitment

Follow-Up Visit(s)

NA