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A Pharmacokinetic Evaluation of the Duration of Effect of Inositol‐Stabilized Arginine Silicate and Arginine Hydrochloride in Healthy Adult Males
Author(s) -
Komorowski James,
Ojalvo Sara Perez
Publication year - 2016
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.30.1_supplement.690.17
Subject(s) - arginine , pharmacokinetics , crossover study , medicine , hydrochloride , pharmacology , endocrinology , chemistry , biochemistry , amino acid , pathology , alternative medicine , placebo
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/m 2 , 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 single‐dose pharmacokinetics on Day 1 are as follows. Plasma arginine levels in the ASI group significantly increased from baseline at 1, 1.5, 2, 3 and 6 hours (p<0.05). Plasma arginine levels in the ArgHCl group only increased at 1 hour (p<0.05). The area under the curve (AUC 0–6hr ) for plasma arginine levels from ASI was 12.68±10.83 compared to 7.40±35.08 for ArgHCl. No safety concerns were raised during the study. This study showed that ASI supplementation significantly increased plasma arginine levels at multiple time‐points up to six hours post‐dose, while ArgHCl supplementation did so for only one hour. This study also showed that ASI supplementation resulted in a >70% increase in plasma arginine AUC compared to ArgHCl, and showed a lower standard deviation than that seen with ArgHCl, suggesting that ASI is a more bioavailable, and less variable, source of arginine. Support or Funding Information This work was supported by Nutrition 21, LLC. 1Percent Change in Plasma Arginine Levels