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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2019-12-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

PBK-1801

Intervention Type DRUG

Administered orally

B

Group Type EXPERIMENTAL

PBK-1801

Intervention Type DRUG

Administered orally

C

Group Type EXPERIMENTAL

PBK-1801

Intervention Type DRUG

Administered orally

Interventions

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PBK-1801

Administered orally

Intervention Type DRUG

PBK-1801

Administered orally

Intervention Type DRUG

PBK-1801

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

Accepts Healthy Volunteers

Yes