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NCT05677035 Clinical Trial

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

Contraception Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05677035
Other study ID # HT-014-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 11, 2022
Est. completion date June 15, 2022

Study information
Verified date January 2023
Source Hyundai Pharm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 15, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: - Women with a Body Mass Index (BMI) between 18kg/m2 ~ 28kg/m2 Exclusion Criteria: - Clinically significant cardiovascular disease, respiratory disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LINO-1713 1 tablet
LINO-1713 1 tablet is administered once. Oral administration with 200mL of water
• LINO-1713 once a day for 24 days
Oral administration is performed with 200 mL of water. Instruct subjects to take the drug at the same time as possible.

Locations
Country Name City State
Korea, Republic of Korea University Anam Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hyundai Pharm

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics parameters: Cmax 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
Primary Pharmacokinetics parameters: Tmax 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
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