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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hyundai Pharm · Industry
• Sex: Female
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Contraception

Interventions

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

Timeline

• Start date: 2022-01-11
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2023-01-10
• Last updated: 2023-01-11

Locations

1 site across 1 country: South Korea