Comparative assessment of the absorption of a generic formulation of atorvastatin oral spray against the innovator atorvastatin capsule conducted under fasting conditions in healthy male and female volunteers

Single dose, two sequence, crossover study design whereby each participant receives the test formulation of atorvastatin oral spray (1 x 8 mg) on one occasion and the innovator formulation of atorvastatin oral capsule (1 x 20 mg) on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of atorvastatin. 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 adverse events 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 will be taken orally with 240 ml of water at ambient temperature. A mouth check will be conducted to ensure the medication has been taken as directed.