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

January 9, 2023 updated by: Hyundai Pharm

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Clinically significant cardiovascular disease, respiratory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacokinetic evaluation
LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
Drug: LINO-1713 1 tablet
LINO-1713 1 tablet is administered once. Oral administration with 200mL of water
Experimental: Pharmacodynamic evaluation
LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyundai Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HT-014-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on LINO-1713 1 tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe