Comparative assessment of the absorption of a generic formulation of phentermine capsule against the innovator phentermine capsule conducted under fed conditions in healthy male and female volunteers in a pilot study

Single dose, crossover study design whereby each participant receives the test formulation of phentermine oral capsule (1 x 40 mg) on one occasion and the innovator formulation of phentermine oral capsul (1 x 40 mg) on one occasion with each dose seperated by a two week washout period. The intervention for this trial is the test formulation of phentermine. 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 receiving breakfast. Subjects will be provided with a standardised high fat breakfast which they must start eating 30 minutes 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 including vital signs. 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 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.