Abstract
The purpose of this randomized, double-blind, active-controlled, crossover study was to evaluate the extent and duration of elevated plasma arginine levels in healthy adult male subjects taking inositol-stabilized arginine silicate (ASI; Nitrosigine®) and arginine hydrochloride (ArgHCl). Prior studies demonstrated enhanced efficacy of ASI over ArgHCl. The current study was designed to evaluate the potential differences in arginine pharmacokinetics between these two complexes, which may help explain the differences in activity. Ten healthy males per treatment group, aged 18 to 40 years, with BMI ≥ 18.5 to < 25 kg/m2, were randomly assigned to take a single oral dose of ASI or ArgHCl (each containing a total of 500 mg of arginine) qd for 14 days, and attended study visits on Days 1 and 15, with a 7-day washout period between test product administration. Fasting blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours post-dose for plasma arginine measurements. The results of the sing...
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