inhibition of ROS production reduction/prevention of myocardial necrosis
Conditions
Interventions
Sulfarlem S25 tablets of 25 mg
intravenous bolus injection and 12-hour infusion of OP2113
intravenous bolus injection and 12-hour infusion of saline placebo
Sponsors
OP2 Drugs
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male and female subjects aged between 18 and 65 years (inclusive) with a body mass index (BMI) of *18.0 kg/m2 and * 30.0 kg/m2 (inclusive) at Screening. Further inclusion criteria can be found in the protocol section 8.4.1
Exclusion criteria
Exclusion criteria: Relevant prior or ongoing medical condition that, in the Investigator*s opinion, could adversely affect the safety of the subject. History of clinically-significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study medication. Further exclusion criteria can be found in the protocol section 8.4.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints of ATT (free) and ATX (free and total) include Cmax, Tmax, AUC0-last, AUC0-inf, AUC0-24,), t1/2, *Z, AR (only for PK samples collected during TID oral dosing). Pharmacokinetic endpoints of ATT (free) only are: CL/F (oral formulation) or CL (i.v. formulation), Vz/F (oral formulation) or Vz (i.v. formulation, C0 (i.v. formulation). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters include adverse events (AEs), vital signs, electrocardiogram (ECG), clinical laboratory assessments and local tolerability (only for i.v. dosing). | — |
Countries
Netherlands
Outcome results
None listed