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OpenTrials
Completed

NCT Number: NCT05677035

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects

A single-center, open-label, parallel-group, phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female subjects

Completed

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Key information

Conditions

Contraception

Age range

19 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women with a Body Mass Index (BMI) between 18kg/m2 ~ 28kg/m2

Exclusion criteria

  • Clinically significant cardiovascular disease, respiratory disease

Treatment and study plan

LINO-1713 1 tablet

Drug

LINO-1713 1 tablet is administered once. Oral administration with 200mL of water

LINO-1713 once a day for 24 days

Drug

Oral administration is performed with 200 mL of water. Instruct subjects to take the drug at the same time as possible.

Primary outcomes

  1. Pharmacokinetics parameters: Cmax

    Time frame: Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours

  2. Pharmacokinetics parameters: Tmax

    Time frame: Before and after administration 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, and 168 hours

Sponsors and collaborators

Lead sponsor

Hyundai Pharm

Industry

Registry information

Official study title

A Single-center, Open-label, Parallel-group, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2023
Registry last updated
Jan 11, 2023

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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