Alzheimer's Disease Psychosis, Schizophrenia
Conditions
Brief 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.
Interventions
DRUGLY03020
single dose，administered orally for each period
Sponsors
Luye Pharma Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum observed concentration (Tmax) of LPM787000048 in plasma | up to Day 12 |
| Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma | up to Day 12 |
| Number of participants with adverse events (AEs). | up to Day 12 |
Countries
China
Outcome results
None listed