Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05855018
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2023-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Atropine Sulfate in Healthy Chinese Volunteers
Sponsor:
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited
Organization:
Study Overview
Official Title:
A Randomized, Open-label Phase I Clinical Study to Evaluate the Systemic Pharmacokinetics and Safety of Atropine Sulfate Eye Drops in Healthy Chinese Volunteers
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
The three treatment arms are:
Atropine sulfate dose A (low concentration)
Atropine sulfate dose B (medium concentration)
Atropine sulfate dose C (high concentration)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: