To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
One drop once daily
HKU Eye Centre
Hong Kong, China
RECRUITINGMaximum concentration (Cmax)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Time of Cmax (Tmax)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Time of half-life (t1/2)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Area Under time-concentration Curve from 0 to last draw time (AUC0-t)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Area Under time-concentration Curve from 0 to infinity time (AUC(0-∞))
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Minimum concentration (Cmin)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Volume of distribution (Vd)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Elimination rate constant (Kel)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Clearance (CL)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Apparent Clearance (CL/F)
Measure the concentration of analyte in the blood to evaluate drug pharmacokinetics
Time frame: From 1 hour before administration to 24 hours after administration
Slit-lamp eye examination results change from baseline to Day 7
Evaluate the anterior segment of the eye, including the eyelids, cornea, conjunctiva, anterior chamber, iris and lens, and record abnormalities
Time frame: on Day 0 and Day 7
Fundoscopy eye examination results change from baseline to Day 7
Evaluate the condition of the fundus, including the vitreous body, optic disc, macula, peripheral retina and retinal blood vessels
Time frame: on Day 0 and Day 7
Intraocular pressure change from baseline to Day 7
Use non-contact tonometer to measure intraocular pressure
Time frame: on Day 0 and Day 7
Vision acuity change from baseline to Day 7
Using Best-corrected LogMAR scale
Time frame: on Day 0 and Day 7
The mean change of pupil diameter from baseline to Day 7
Use ophthalmic biometry equipment to measure pupil diameter
Time frame: on Day 0 and Day 7
The mean change of accommodation amplitude from baseline to Day 7
Use a Phoropter to measure the accommodation amplitude using the negative lens method
Time frame: on Day 0 and Day 7