Comparative assessment of the absorption of a generic formulation of 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w trandermal patch against the innovator 32-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w trandermal patch conducted under fasting conditions in healthy male and female volunteers.

Single dose, crossover study design whereby each participant receives the test formulation of 2 x 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w patches on one occasion and the innovator formulation 2 x 2-(diethylamino-N-(2,6-dimethylphenyl)acetamide 5% w/w patches on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test patch formulation The two transdermal patches will be applied to the lower mid back area and kept in place for 12 hours. In the second study period the patches will be applied on the contralateral side of the body. No water is allowed for 1 hour prior to dosing until 1 hour after dosing. Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 24 hours after dosing. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Screening and study exit laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing.