Trials / Unknown
UnknownNCT05855018
A Study of Atropine Sulfate in Healthy Chinese Volunteers
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atropine sulfate eye drops | One drop once daily |
Timeline
- Start date
- 2023-05-09
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
- First posted
- 2023-05-11
- Last updated
- 2023-05-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05855018. Inclusion in this directory is not an endorsement.