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

Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: LINO-1713 1 tablet; Drug: LINO-1713 once a day for 24 days

• Registration Number: NCT05677035
• Lead Sponsor: Hyundai Pharm

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-11
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Study First Submitted: 2022-12-21
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-09
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Clinically significant cardiovascular disease, respiratory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic evaluation	LINO-1713 1 tablet	LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
Pharmacodynamic evaluation	LINO-1713 once a day for 24 days	LINO-1713 (Estetrol 15mg/Drospirenone 3mg)

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of