NCT07292233Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 6 Aug 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 27 Aug 2025
- Lead sponsor
- Luye Pharma Group Ltd.
- Diseases
- Schizophrenia, Alzheimer disease
- NCT number
- NCT07292233
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 16
- From 30 Jul 2025 to the primary completion date, 27 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.
Other illness
- 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 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.
Lab values
- Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anding Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.