Superficial infantile hemangioma in proliferative stage
Conditions
Interventions
Test group:The subject should use 0.5% thiamol maleate eye gel solution once a day at the same time on an empty stomach, with one drop in each eye on both sides
Sponsors
Huzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Age and gender: Healthy male or female participants aged 18 to 50, including threshold values; 2) Body mass index: Male weight = 50 kg, female weight = 45 kg, body mass index (BMI) between 19 and 26 kg/m2 (including boundary values), BMI=weight (kg)/height 2 (m2); 3) The screening period ophthalmic examination includes visual acuity, color vision, intraocular pressure, slit lamp examination (eyelid, lacrimal organ, anterior chamber, conjunctiva, etc.), and fundus examination, all of which are normal or abnormal without clinical significance; 4) Refractive myopia<600 degrees, corrected visual acuity in both eyes = 0.8; 5) Vital sign examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, infectious disease examination, coagulation function), pregnancy examination (for women of childbearing age), 12 lead electrocardiogram, if the results show no abnormalities or no clinical significance; 6) Male participants and their partners or female participants must agree to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive rings, partner ligation, etc.) during the trial period and within 3 months after the end of the trial, and there is no plan to donate sperm or eggs; 7) Fully understand the experimental content, experimental drugs, experimental process, etc., be able to communicate well with researchers, willing to comply with research regulations, and voluntarily sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1) (Screening period consultation+check-in consultation) Patients with respiratory system (especially bronchial asthma, bronchospasm, chronic obstructive pulmonary disease), cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematology, immunology, mental illness or family history of hereditary mental illness, tumors, etc., who the researchers believe still have clinical significance; 2) (Interview during screening period) Those who have ever suffered from diabetes, thyrotoxicosis, cardiogenic shock, ? - ? degree atrioventricular block, heart failure, significant sinus bradycardia, hypotension, sick sinus syndrome, severe peripheral vascular disease with resting ischemia, and who are clinically significant if judged abnormal by the research doctor; 3) (Screening period consultation+check-in consultation) Patients who have undergone surgery within 6 months prior to the first medication administration that has been determined by the researcher to affect drug absorption, distribution, metabolism, and excretion; Or underwent surgery within 4 weeks before the first administration; Or those who plan to undergo surgical procedures during the trial period; 4) (Screening period consultation) Individuals who have previously or currently suffered from any acute or chronic eye disease, or those who have had a mixed infection, inflammation, trauma, or other eye disease with significant clinical significance (keratoconus, severe dry eye syndrome), active eye disease, acute or chronic allergic eye disease, or any abnormalities in the eyelid, ocular surface, or lacrimal duct system that the researcher believes may affect the absorption of eye drops within one month prior to the first administration; 5) (Screening period consultation) Individuals with a history of eye trauma or eye surgery; 6) If the intraocular pressure test exceeds the normal range (10-21 mmHg), the binocular pressure difference is greater than 5 mmHg, and the research doctor determines that the abnormality has clinical significance; 7) Individuals with corneal lesions, corneal thickness greater than 600 µ m (normal central corneal thickness of 500-600 µ m), corneal scars, wearing contact lenses (including night wear corneal reshaping lenses), or the need to wear contact lenses during the study period that affect intraocular pressure measurement, and the research doctor's judgment that abnormalities have clinical significance; 8) (Screening period consultation) Evidence or medical history of acute or chronic angle closure glaucoma in the past; 9) (Screening period consultation+check-in consultation) Within 30 days before the first administration, any medication that inhibits or induces liver drug metabolism enzymes or interacts with the study drug (adrenergic receptor inhibitors, digitalis and calcium antagonists, catecholamine consuming drugs, clonidine, quinidine, etc.) has been used; 10) Individuals who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, vaccines, or health products for various reasons within 14 days prior to the first administration of the trial (screening period consultation+check-in consultation); 11) (Screening period consultation) Individuals who are allergic to Thialol Maleate Eye Gel Solution or its excipients; Or those who have accumulated two or more allergies to other drugs, food, or the environment; Individuals with a constitution prone to allergic symptoms such as rash (systemic ras
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss;AUC0-24,ss;AUC0-t,ss;AUC0-8,ss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmin,ss;Cav,ss;Tmax,ss;t1/2,ss; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital
Outcome results
None listed