Background: Acute myocardial infarction (AMI) has remained a leading cause of mortality and disability worldwide. Although percutaneous coronary angioplasty (PCA) is the best treatment for these patients, paradoxically this procedure causes reperfusion injury. Considerable efforts aimed to reduce this damage have been made, but the results are disappointing and there is still no effective therapy for preventing the damage. Previously, the investigators have achieved a reduction of infarct size in an experimental model of an isolated rat heart, through a synergistic effect of three compounds in a "combined antioxidant therapy" (CAT). In this study, the investigators aim to describe the pharmacokinetics and safety of CAT intravenously administered to healthy subjects. This is the first step to a later clinical application of CAT in AMI patients. Methodology: The safety and pharmacokinetics of the CAT (deferoxamine, N-acetylcysteine, and ascorbate) will be assessed in healthy volunteers in a "phase I clinical trial". Two different formulations (mass of CAT components by bag) with different infusion rates each one will be tested (CAT1 and CAT2). Subjects (18-35 years old, n=18) will be randomized 1:2 to receive a placebo or CAT for 90 minutes. Blood concentrations of each CAT component will be measured in plasma at 0, 15, 30, 60, 90, 120, and 180 minutes after the infusion onset. Adverse events will be registered from the onset of infusion until day 30.
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Peak plasma concentration (Cmax) of each CAT component
Timeframe: 180 minutes (just before the infusion onset up to 90 minutes after infusion ending)
Half-life time (T1/2) of each CAT component
Timeframe: 180 minutes (just before the infusion onset up to 90 minutes after infusion ending)
Area under the plasma concentration versus time curve (AUC) of each CAT component
Timeframe: 180 minutes (just before the infusion onset up to 90 minutes after infusion ending)
Volume of distribution (Vd) of each CAT component
Timeframe: 180 minutes (just before the infusion onset up to 90 minutes after infusion ending)
Clearence (CL) of each CAT component
Timeframe: 180 minutes (just before the infusion onset up to 90 minutes after infusion ending)
Elimination rate constant (Ke) of each CAT component
Timeframe: 180 minutes (just before the infusion onset up to 90 minutes after infusion ending)
Incidence of serious adverse events during combined antioxidant therapy infusion or along the 30-day follow-up
Timeframe: From day 0 to day 30 after the intervention