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

Sponsor
Hyundai Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT05677035
Collaborator
(none)
20
1
2
5.1
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: LINO-1713 1 tablet
  • Drug: LINO-1713 once a day for 24 days
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 11, 2022
Actual Primary Completion Date :
Jun 15, 2022
Actual Study Completion Date :
Jun 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea University Anam Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Hyundai Pharm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hyundai Pharm
ClinicalTrials.gov Identifier:
NCT05677035
Other Study ID Numbers:
  • HT-014-01
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 11, 2023