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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05677035

Enrollment

Registered

2023-01-10

Start date

2022-01-11

Completion date

2022-06-15

Last updated

2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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

Interventions

DRUGLINO-1713 1 tablet

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

DRUGLINO-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Clinically significant cardiovascular disease, respiratory disease

Design outcomes

Primary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026