Clinical Trials/NCT05677035

NCT05677035

Completed

Phase 1

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

Hyundai Pharm1 site in 1 country20 target enrollmentJanuary 11, 2022

ConditionsContraception

InterventionsLINO-1713 1 tablet LINO-1713 once a day for 24 days

Overview

Phase: Phase 1
Intervention: LINO-1713 1 tablet
Conditions: Contraception
Sponsor: Hyundai Pharm
Enrollment: 20
Locations: 1
Primary Endpoint: Pharmacokinetics parameters: Cmax
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 11, 2022

End Date

June 15, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Hyundai Pharm

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Clinically significant cardiovascular disease, respiratory disease

Arms & Interventions

Pharmacokinetic evaluation

LINO-1713 (Estetrol 15mg/Drospirenone 3mg)

Intervention: LINO-1713 1 tablet

Pharmacodynamic evaluation

LINO-1713 (Estetrol 15mg/Drospirenone 3mg)

Intervention: LINO-1713 once a day for 24 days

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

Study Sites (1)

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