Comparative assessment of the absorption of a generic formulation of 15 mg alpha,alpha-dimethylphenethylamine tablet against the innovator 15 mg alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions in healthy male and female volunteers.

INTERVENTION: Single dose, crossover study design whereby each participant receives the test formulation of alpha,alpha‐dimethylphenethylamine oral tablet (1 x 15 mg) on one occasion and the innovator formulation of alpha,alpha‐dimethylphenethylamine oral capsule (1 x 15 mg) on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test tablet formulation. 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 10 hours prior to dosing. Subjects are required to fast for 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 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 15 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. CONDITION: alpha,alpha‐dimethylphenethylamine is a C5 Controlled Drug indicated in the management of obesity as a short‐term adjunct in a medically monitored comprehensive regime of weight reduction. PRIMARY OUTCOME: To compare the bioavailability of alpha,alpha‐dimethylphenethylamine (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for alpha,alpha‐dimethylphenethylamine using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. SECONDARY OUTCOME: Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points. INCLUSION CRITERIA: Healthy male and non‐pregnant females Aged between 18 and 55 Non‐smoker BMI between 18 and 30 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent