Healthy Volunteer
Conditions
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.
Interventions
DRUGPBK-1801
Administered orally
Sponsors
Pharmbio Korea Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vd/F | 5 days |
| Cmax | 5 days |
| AUClast | 5 days |
| AUCinf | 5 days |
| Tmax | 5 days |
| T1/2 | 5 days |
| CL/F | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events | 30 days |
Countries
South Korea
Outcome results
None listed