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
3.9
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 |
---|---|---|
|
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
- 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]
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