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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ACTIVE_NOT_RECRUITING
PHASE1
16 participants
INTERVENTIONAL
2025-07-30
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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fasted,fed
Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively.
LY03020
single dose，administered orally for each period
fed,fasted
Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively.
LY03020
single dose，administered orally for each period
Interventions
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LY03020
single dose，administered orally for each period
Eligibility Criteria
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Inclusion Criteria
* Male or female aged 18 to 45 years.
* Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.
Exclusion Criteria
* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
* Subjects with a history of orthostatic hypotension or syncope.
* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.
* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation.
* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.
18 Years
45 Years
ALL
Yes
Sponsors
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Luye Pharma Group Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing AnDing Hospital Capital Medical University
Beijing, , China
Countries
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Other Identifiers
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LY03020/CT-CHN-102
Identifier Type: -
Identifier Source: org_study_id