drugset / Trial / NCT06127368
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM and SC depot in healthy male Adults. And, It is to evaluate pharmacokinetic characteristics of GB-5001 (donepezil) IM and SC single dose injection vs. active comparator.
Timeline
- Start
- 2024-01-03
- Primary completion
- 2024-09-17
- Completion
- 2025-01-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donepezil | Small molecule | — | Intramuscular |