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

Hyundai Pharm20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contraception

Interventions

LINO-1713 1 tabletDRUG

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

LINO-1713 once a day for 24 daysDRUG

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

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women with a Body Mass Index (BMI) between 18kg/m2 \~ 28kg/m2 Exclusion Criteria: * Clinically significant cardiovascular disease, respiratory disease

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.