Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women

A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers

The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.

Inclusion Criteria:

• Body Mass Index (BMI) between 19 and 30 kg/m²
• Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
• Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions

Exclusion Criteria:

• History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
• Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
• History or current alcohol abuse or drug addiction
• Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study