Comparative assessment of the absorption of a test formulation of 1 x 12 mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsule against the innovator 2x 10 mg (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid capsules conducted under fed conditions in healthy male volunteers.

Single dose, crossover study design whereby each participant receives the test formulation of (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid, 1 x 12 mg capsule on one occasion and the innovator formulation of (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid, 2 x 10 mg capsules on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test formulation of (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before receiving a standardised high fat content meal and to fast for approximately 4 hours after each dose. The high fat content meal will consist of 2 eggs fried in butter, 2 slices of white toast, 120g hash brown patties, 2 slices of bacon and 240mL of whole milk comprising of approximately 800 to 1000 calories (approximately 50% of total caloric content of the meal derived from fat). This test meal will derive approximately 150, 250, and 500 600 calories from protein, carbohydrate, and fat, respectively. Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 12 hours after dosing. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing & urine drugs of abuse will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of the 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 that the medication has been taken as directed.