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

Pharmbio Korea Co., Ltd.1 site in 1 country36 target enrollmentOctober 24, 2019

ConditionsHealthy Volunteer

InterventionsPBK-1801

DrugsPBK-1801

Overview

Phase: Phase 1
Intervention: PBK-1801
Conditions: Healthy Volunteer
Sponsor: Pharmbio Korea Co., Ltd.
Enrollment: 36
Locations: 1
Primary Endpoint: AUCinf
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 24, 2019

End Date

December 23, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Investigators

Sponsor

Pharmbio Korea Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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