Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Luye Pharma Group Ltd.
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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.
