drugset / Trial / NCT07429565
Testing APPA-1 in Healthy Subjects and Osteoarthritis Patients
RandomizedSequentialQuadruple-blindTreatment
Summary
To determine the safety and tolerability of ascending single and multiple oral doses of APPA-1 in healthy subjects and osteoarthritis patients. To determine the single and multiple oral dose pharmacokinetics of APPA-1 constituents (paeonol/apocynin) in healthy subjects and osteoarthritis patients. To determine the effect of food on the single oral dose pharmacokinetics of APPA-1 constituents (paeonol/apocynin) in healthy subjects. To determine the effect of gender on the single oral dose pharmacokinetics of APPA-1 constituents (paeonol/apocynin) in healthy subjects. To determine the multiple oral dose pharmacodynamics of APPA-1 in osteoarthritis patients.
Timeline
- Start
- 2018-04-09
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APPA-1 | Unknown | 400 mg | Oral |
| Subject | APPA-1 | Unknown | 800 mg | Oral |
| Subject | APPA-1 | Unknown | 1600 mg | Oral |
| Subject | APPA-1 | Unknown | 3200 mg | Oral |