drugset / Trial / NCT06824948
Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical trial is to to evaluate the safety, tolerance, and pharmacokinetic profiles of Timolol Maleate Gel in healthy Chinese adult subjects. The main questions aim to answer are: • The pharmacokinetic endpoints: Single dose:Tmax, Cmax, etc. Multiple doses:AUC0-t, AUC0-inf, λz, t1/2, etc. • The safety and tolerance endpoints: Physical examination, vital signs, 12-lead ECG, laboratory tests (hematology, blood biochemistry and urinalysis), adverse events, local tolerance. Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.
Timeline
- Start
- 2018-10-12
- Primary completion
- 2018-12-12
- Completion
- 2018-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Timolol | Other / unclassified | 0.5 % | Topical |
Indications
No indication recorded.