A Food Effect Study of LY03020 in Healthy Subjects

A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects

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.

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.