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

Hyundai Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Contraception

Treatments: Drug: LINO-1713 once a day for 24 days; Drug: LINO-1713 1 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05677035

HT-014-01

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Clinically significant cardiovascular disease, respiratory disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Pharmacokinetic evaluation

Experimental group

Description:

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

Treatment:

Drug: LINO-1713 1 tablet

Pharmacodynamic evaluation

Experimental group

Description:

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

Treatment:

Drug: LINO-1713 once a day for 24 days