Status:
COMPLETED
Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women
Lead Sponsor:
Pharmbio Korea Co., Ltd.
Conditions:
Healthy Volunteer
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04418388
Start Date
October 24 2019
End Date
December 23 2019
Last Update
June 5 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea