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

NCT04418388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-06-05

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

PBK-1801

Administered orally

DRUG

PBK-1801

Administered orally

DRUG

PBK-1801

Administered orally

Sponsors & Collaborators

  • Pharmbio Korea Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • SeungHwan Lee · Seoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2019-12-03
Completion
2019-12-23
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418388 on ClinicalTrials.gov