Pharmacokinetics
Conditions
Brief summary
To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.
Detailed description
This is a randomized, open-label, phase I clinical study evaluating the systemic pharmacokinetics and safety of atropine sulfate eye drops in healthy Chinese volunteers.Three concentrations will be investigated, each concentration group must contain both male and female subjects, and each subject receives only one concentration of atropine sulfate eye drop in this study. The three treatment arms are: Atropine sulfate dose A (low concentration) Atropine sulfate dose B (medium concentration) Atropine sulfate dose C (high concentration)
Interventions
DRUGAtropine sulfate eye drops
One drop once daily
Sponsors
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subject is a male or female Chinese with his/her biological parents and grandparents are of Chinese ethnicity, aged 18-45 (including cut-off value) at screening; 2. Subject with a body mass index (BMI) between 19.0-26.0kg/m2 (including cut-off value), male weight ≥50.0kg, female weight ≥45.0kg at screening and D0; 3. Subject is in good health, as determined by the investigator, based on medical history, no findings of clinical significant abnormalities at physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening and D0;
Exclusion criteria
1. Subject with any eye with corrected visual acuity \<1.0, clinically significant abnormal intraocular pressure, slit lamp and fundus examination. 2. Subject with history of eye diseases, including the history of internal eye surgery or laser surgery. 3. Subject with clinically significant history of the central nervous system, mental, cardiovascular, kidney, liver, respiratory, metabolic, and musculoskeletal system diseases etc., which may endanger the safety of the subject or affect the results of the study, as judged by the investigator. 4. Subject with clinically significant history of allergies, such as drug allergies, especially those who are allergic to any component of atropine sulfate eye drops. 5. On average, subject smokes more than 5 cigarettes per day or that who ex-smokes less than 3 months. 6. Subject has used any topical or systemic antimuscarinic/anticholinergic drugs (e.g., atropine, 1-hyoscyamine, tropicamide, chlorpheniramine, diphenhydramine, oxytropine, cyclic antidepressants, etc.) within 3 weeks before screening. 7. Subject has used any local or systemic drugs (including any prescription or over-the-counter drugs) within 2 weeks before screening. 8. Subject has participated in interventional clinical trials within 3 months before screening. 9. Subject who has worn contact lenses or cosmetic contact lenses within 1 weeks before screening. 10. Subject who is pregnant or breastfeeding. 11. The investigator believes that the subject is not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Clearance (CL/F) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Area Under time-concentration Curve from 0 to last draw time (AUC0-t) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Area Under time-concentration Curve from 0 to infinity time (AUC(0-∞)) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Minimum concentration (Cmin) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Volume of distribution (Vd) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Elimination rate constant (Kel) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Clearance (CL) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Maximum concentration (Cmax) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Time of Cmax (Tmax) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
| Time of half-life (t1/2) | From 1 hour before administration to 24 hours after administration | Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit-lamp eye examination results change from baseline to Day 7 | on Day 0 and Day 7 | Evaluate the anterior segment of the eye, including the eyelids, cornea, conjunctiva, anterior chamber, iris and lens, and record abnormalities |
| Intraocular pressure change from baseline to Day 7 | on Day 0 and Day 7 | Use non-contact tonometer to measure intraocular pressure |
| Vision acuity change from baseline to Day 7 | on Day 0 and Day 7 | Using Best-corrected LogMAR scale |
| The mean change of pupil diameter from baseline to Day 7 | on Day 0 and Day 7 | Use ophthalmic biometry equipment to measure pupil diameter |
| The mean change of accommodation amplitude from baseline to Day 7 | on Day 0 and Day 7 | Use a Phoropter to measure the accommodation amplitude using the negative lens method |
| Fundoscopy eye examination results change from baseline to Day 7 | on Day 0 and Day 7 | Evaluate the condition of the fundus, including the vitreous body, optic disc, macula, peripheral retina and retinal blood vessels |
Countries
China
Contacts
Primary ContactChristopher LEUNG
Outcome results
None listed