drugset / Trial / NCT07799090
Pharmacokinetic Study of GB-5001A 280 mg Long Acting Injection, in Comparison With the Comparator Drug Aricept® 5 mg and Aricept® 10 mg Film-coated Tablet in Healthy Subjects
RandomizedParallel-groupOpen-labelBasic science
Summary
This study is to find out whether the bioavailability of GB-5001A 280 mg Injection is compared to the comparator drug of Aricept® 5 mg and Aricept® 10 mg which are Film-Coated Tablet when administered in healthy subjects. Also to monitor the adverse events and to ensure the safety of the subjects.
Timeline
- Start
- 2025-08-12
- Primary completion
- 2026-04-15
- Completion
- 2026-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donepezil | Small molecule | 5 mg | Oral |
| Subject | Donepezil | Small molecule | 10 mg | Oral |
| Subject | GB 5001A | Unknown | 280 mg | — |
Indications
No indication recorded.