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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: PBK-1801

• Registration Number: NCT04418388
• Lead Sponsor: Pharmbio Korea Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-23
• Study First Submitted: 2020-05-26
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-02
• Last Update Submitted: 2020-06-02
• Study First Posted: 2020-06-05
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
B	PBK-1801	-
A	PBK-1801	-
C	PBK-1801	-

Primary Outcome Measures

Name	Time	Method
AUCinf	5 days
Tmax	5 days
T1/2	5 days
Cmax	5 days
AUClast	5 days
CL/F	5 days
Vd/F	5 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	30 days

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of