Comparative assessment of the absorption of a generic formulation of 5 mg bis [(E)-7-[4-(4-fluorophenyl)- 6-isopropyl-2- [methyl(methylsulfonyl) amino]pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt orally disintegrated tablet (ODT) against the innovator 40 mg bis [(E)-7-[4-(4-fluorophenyl)- 6-isopropyl-2- [methyl(methylsulfonyl) amino]pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt oral tablet conducted under fasting conditions in healthy volunteers.

Single dose, crossover study design whereby each participant receives the test formulation of 1 x 5 mg bis [(E)-7-[4-(4-fluorophenyl)- 6-isopropyl-2- [methyl(methylsulfonyl) amino]pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt orally disintegrated tablet (ODT) on one occasion and the innovator formulation of 1 x 40 mg bis [(E)-7-[4-(4-fluorophenyl)- 6-isopropyl-2- [methyl(methylsulfonyl) amino]pyrimidin-5-yl] (3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt oral tablet on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test ODT formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the comparator treatment). Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose. 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 24 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. The actual meals provided will be determined based on the menu in operation at the time of study conduct. As a guide the lunch and dinner meals will consist of a medium sized serving of meat, vegetables and dessert with fruit available in the evening. A vegetarian option may be available. The meals will not contain any chocolate or citrus products. Alcohol breath testing and dipstick drugs of abuse tests will be performed upon each participant reporting to the clinical site 12 hours prior to dosing. Screening procedures including laboratory tests and medical examinations will be completed to assess the health of the participants. Study exit procedures will be completed within one week after receiving the last dose. The test product will be administered under the tongue (sublingually) until completely dissolved and the reference dose will be taken orally with 240 ml of water at ambient temperature. The Reference medication must be swallowed whole and a mouth check will be conducted to ensure that each medication has been taken as directed.