Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects
NCT ID: NCT05677035
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2022-01-11
2022-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pharmacokinetic evaluation
LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
LINO-1713 1 tablet
LINO-1713 1 tablet is administered once. Oral administration with 200mL of water
Pharmacodynamic evaluation
LINO-1713 (Estetrol 15mg/Drospirenone 3mg)
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.
Interventions
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LINO-1713 1 tablet
LINO-1713 1 tablet is administered once. Oral administration with 200mL of water
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
50 Years
FEMALE
Yes
Sponsors
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Hyundai Pharm
INDUSTRY
Responsible Party
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Locations
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Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HT-014-01
Identifier Type: -
Identifier Source: org_study_id
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