A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel With Timolo… (NCT06813807) | Clinical Trial Compass
CompletedPhase 1
A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel With Timolol Maleate Gel
China18 participantsStarted 2024-06-15
Plain-language summary
The goal of this clinical trial is:
1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects.
The main questions aim to answer are:
* Pharmacokinetic (PK) profiles of healthy adult subjects
* Safety Evaluation
* To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age and gender: Healthy male or female subjects aged 18 to 50 years old (inclusive);
. Weight: ≥ 50 kg for male, ≥ 45 kg for female; body mass index (BMI) between 19 and 26 kg/m2 (inclusive), where BMI = weight (kg) / height2 (m2);
. Ophthalmic examinations during screening include visual acuity, color vision, intraocular pressure, slit-lamp examination (of eyelids, lacrimal apparatus, anterior chamber, conjunctiva, etc.) and fundus examination must be normal or abnormal without clinical significance;
. Refractive myopia \< 600 degrees, corrected visual acuity ≥ 0.8 in both eyes;
. Subjects with no abnormal or with abnormal but not clinically significant results in vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, blood biochemistry, infectious disease test and coagulation function), pregnancy test (women of childbearing age), and 12-lead ECG;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Male subjects and their partners or female subjects must agree to take one or more non-drug contraceptive measures (such as complete abstinence, intrauterine ring and partner ligation) during the study and for 3 months after the end of the study, and have no plan of sperm or egg donation; Subjects have a full understanding of the study content, investigational drugs, study process, etc., and are able to communicate well with the investigator, willing to comply with the study regulations, and voluntarily sign the informed consent form.
Exclusion criteria
. (Screening period inquiry + check-in inquiry) Subjects with a history of respiratory system (especially bronchial asthma, bronchospasm, chronic obstructive pulmonary disease), cardiovascular system, digestive system, endocrine system, urinary system, nervous system, hematological, immunological, psychiatric disorders or a family history of genetic psychosis, cancer, etc., and are considered by the investigator to still have clinical significance;
. (Screening period inquiry) Subjects with a history of diabetes, thyrotoxicosis, cardiogenic shock, second- to third-degree atrioventricular block, heart failure, significant sinus bradycardia, hypotension, sick sinus syndrome, severe peripheral vascular disease with resting ischemia and whose condition is assessed by the study physician to be abnormal but clinically significant;
. (Screening period inquiry + check-in inquiry) Subjects who have undergone surgery within 6 months before the first dose that will affect drug absorption, distribution, metabolism and excretion as judged by the investigator; or who have undergone surgery within 4 weeks before the first dose; or who plan to undergo surgery during the study period;
. (Screening period inquiry) Subjects with a history of or currently suffering from any acute and chronic eye diseases, or with ocular mixed infections, inflammation, trauma or other ophthalmic conditions with clinical significance(e.g., keratoconus, severe dry eye) within 1 month before the first dose, active eye diseases, or acute or chronic allergic eye diseases or any abnormalities in the eyelids, ocular surface, and lacrimal passage system that may affect the absorption of eye drops in the opinion of the investigator;
. (Screening period inquiry) Subjects with a history of ocular trauma or eye surgery;
. Subjects whose elevated intraocular pressure exceeds the normal range (10 \~ 21 mmHg), with the pressure difference of greater than 5 mmHg between both eyes and considered clinically significant by the study doctor;
. Subjects with keratopathy, corneal thickness greater than 600 um (normal central corneal thickness is 500 \~ 600 um) or corneal scarring, wearing contact lenses (including night wear orthokeratology lenses) or having to wear contact lenses during the study, which affect the intraocular pressure measurement and are considered clinically significant by the study physician;
. (Screening period inquiry) Those with evidence or a history of acute and chronic angle-closure glaucoma;