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OpenTrials
Completed

NCT Number: NCT04418388

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

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.

Completed

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Key information

Conditions

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBK-1801

Drug

Administered orally

Primary outcomes

  1. Cmax

    Time frame: 5 days

  2. AUClast

    Time frame: 5 days

  3. AUCinf

    Time frame: 5 days

  4. Tmax

    Time frame: 5 days

  5. T1/2

    Time frame: 5 days

  6. CL/F

    Time frame: 5 days

  7. Vd/F

    Time frame: 5 days

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Pharmbio Korea Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 5, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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