A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet

Inclusion Criteria

• Overtly healthy males or females, as determined by medical history and physical examination
• Are either women who are of child-bearing potential, surgically sterilised or defined as post-menopausal. Female subjects of child-bearing potential (not surgically sterilised between menarche and menopause) must have a negative pregnancy test at the time of screening and must be using a reliable method of birth control. These include tubal ligation, an intrauterine device which has been in place for at least 3 months, the oral contraceptive pill which has been taken, without difficulty, for at least 3 months, or an approved hormonal implant. Barrier methods alone (condoms or diaphragm/cap) are not acceptable, but must be used in conjunction with a chemical method, that is, spermicidal gel. A woman is presumed to be post-menopausal if she has had amenorrhoea for greater than 12 months alone or amenorrheic for 6 to 12 months and has a serum oestradiol concentration 40 international units per liter (IU/L).
• Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
• Between the body mass index (BMI) of 18.5 and 32.0 kilograms per meter squared (kg/m^2), inclusive
• Have acceptable blood pressure (BP) and heart rate (HR) (supine) as determined by the investigator
• Have venous access sufficient to allow blood sampling
• Are reliable and willing to make themselves available for the duration of the study, and will abide by the research unit policy and procedure and study restrictions
• Have given written informed consent approved by Lilly and the Ethical Review Board (ERB) governing the site

Exclusion Criteria

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data, as determined by the investigator
• Evidence of significant active neuropsychiatric disease
• Have a history or presence of significant bleeding disorders, that is, haematemesis, melaena, severe or recurrent epistaxis, haemoptysis, haemorrhage, clinically overt haematuria, or intracranial haemorrhage
• Have a history (within the last 5 years) or presence of gastric ulcers. Previous history of duodenal ulcer is acceptable but must have been successfully surgically or medically treated with no further evidence of disease in the past 6 months (from screening)
• Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, for example, cerebral haemorrhage, aneurysm, or premature stroke (cerebrovascular accident <65 years of age)
• Have a self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction)
• Are pre-menopausal females with a history or presence of menorrhagia within the last 5 years (from screening)
• Have clinically significant out of range values for prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count at screening
• Have repeatedly reported positive results (at least 2 separate samples) on the faecal occult blood examination
• Have a history of major surgery within 3 months of screening
• Have planned surgery within 14 days after the last study day
• Have a clinically significant abnormality in fundoscopic examination or petechiae examination
• Have any other clinically significant abnormality following the investigator's review of the prestudy physical examination, electrocardiogram (ECG) and clinical (safety) laboratory tests
• Regularly use known drugs of abuse and/or show unacceptable positive findings on urinary drug screening
• Have known allergies or significant hyperse