drugset / Trial / NCT07429565

Testing APPA-1 in Healthy Subjects and Osteoarthritis Patients

NCT07429565 ↗

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

EvaluationDrugModalityDoseRoute
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

Indications