Comparative assessment of the absorption of a generic formulation of alpha,alpha-dimethylphenethylamine tablet against the innovator alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions and at steady state in healthy male and female volunteers.

Mutliple dose, crossover study design whereby each participant receives the test formulation of alpha,alpha-dimethylphenethylamine oral tablet (1 x 40 mg) on five occasions and the innovator formulation of alpha,alpha-dimethylphenethylamine oral capsule (1 x 40 mg) on five occasions with each dose separated by a 10 day washout period. The intervention for this trial is the test tablet formulation. On study days 1-5 subjects will receive 5 daily doses of one formulation (either the test or innovator) and on study days 15-19 they will receive 5 daily doses of the other formulation (either the innovator or test). Each dose (1 x 40 mg) will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose). Participants are required not to eat for 4 hours before receiving each dose on study days 1 to 4 and 15 to 18. On study days 1 and 15 subjects will report to the Zenith Clinical Site for dosing and observation of adverse events and the provision of one blood sample. They are required to stay at the clinical site for 24 hours after dosing. On study days 2 to 4 and 16 to 18 subjects will report to Zenith Technology for dosing and the provision of one blood sample. On study day 5 and 19 no water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose) and subjects are required to fast for 8 hours prior to receiving the dose and approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 8 hours prior to dosing to ensure compliance can be monitored and for 24 hours after dosing. Standard meals will be consumed at the Clinical Site on study days 5 and 19 with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing.