Comparative assessment of the absorption of a generic formulation of 1,1-Dimethyl-2-Phenylethylamine capsule against the innovator 1,1-Dimethyl-2-Phenylethylamine capsule conducted under fed condition in healthy male and female volunteers.

Single dose, crossover study design whereby each participant receives the test formulation of 40 mg 1,1-Dimethyl-2-Phenylethylamine capsule on one occasion and the innovator formulation of 40 mg 1,1-Dimethyl-2-Phenylethylamine capsule on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test capsule formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the dose). Participants are required not to eat for 10 hours before receiving breakfast and to fast for approximately 4 hours after receiving each dose. A standardised high-fat content breakfast must be consumed and participants must start eating the breakfast 30 minutes prior to dosing. Bathroom visits will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 24 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours 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. 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.