LY03020: single dose,administered orally for each period
Study summary
This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Subjects sign informed consent voluntarily.
* 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 have any clinically significant medical condition or chronic disease.
* 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.
Primary outcome measure(s)
Maximum observed concentration (Cmax) of LPM787000048 in plasma — up to Day 12
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma — up to Day 12
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma — up to Day 12
Trial sites (1)
Facility
City
Region
Status
Beijing AnDing Hospital Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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