Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects

[Pharmacokinetics Assessment]

• Primary Parameter

• AUC0-t
• Secondary Parameters - Cmax, tmax

[Safety Assessment]

• Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory tests

Inclusion criteria

• Healthy adults aged between 19-45
• Body weight ≥ 50kg and in the range of ideal body weight ± 20%
• Without congenital, or chronic diseases within recent 5 years
• Subjects who are deemed eligible based on the screening tests
• Subjects who received a full explanation of the study, understood the purpose and details of this study, characteristics of the investigational product, and expected adverse events, and voluntarily signed the informed consent form
• Agree to use acceptable contraceptive methods from signing the informed consent to 3 weeks after the last dose of the investigational product
• Able and willing to comply with study requirements including all scheduled inpatient and outpatient visits, clinical laboratory tests, and instructions.

Exclusion criteria

• A subject with symptoms suspected of acute illness at the screening
• A subject with clinically significant and active cardiovascular, respiratory, kidney, endocrine, hematological, gastrointestinal, central nervous system diseases, psychiatric disorders, or malignant tumors
• A history of gastrointestinal disease
• Known hypersensitivity to the active ingredient or excipients of investigational product or a history of clinically significant hypersensitivity
• A history of drug abuse
• Pregnant women or women who may be pregnant, and breastfeeding women
• Subjects who are deemed inappropriate to participate in the study by the investigator for other reasons