Search

Considerable risk of iron deficiency has been identified in premenopausal women because of the adverse effects associated with commercial iron preparations. This study examined the safety and tolerability of a novel iron multi-amino acid chelate (IMAAC) preparation in premenopausal women. A single-centre, randomized, double-blind, three-arm placebo-controlled ( n = 60) study was conducted where subjects received one of three test materials: IMAAC (600 mg) or ferrous sulfate (600 mg) each containing 25 mg of elemental iron, or placebo as a single daily dose for 7 days. After testing, there were no significant differences found in any of the hematological outcomes between the different test groups. The safety analyses showed that a significantly ( p = .044) higher number of patients reported adverse events when taking the ferrous sulfate supplement compared to IMAAC. A significantly lower number of adverse effects ( p = .008) were reported by subjects on IMAAC. The current study demonstrated the superiority of the IMAAC preparation over ferrous sulfate with regards to tolerability and adverse effects. [ABSTRACT FROM AUTHOR]

The pharmacokinetics of a single 30-mg dose of a novel enteric-coated coenzyme Q10 (CoQ10) formulation with pyridoxal 5′-phosphate and phosphatidyl choline (CoQ10-P5P-PC) was investigated against two comparators CoQ10 (NPN 02176955) and CoQ10 (DIN 02231736) in 21 healthy volunteers, with screening CoQ10 levels of 0.8 ± 0.2 mg/L. A randomized, double-blind, crossover study was designed with a washout period of 2 weeks between each formulation and blood sampled at 2, 4, 5, 6, 8, 12, 24, 48 and 72 hr postdose. Significantly, higher plasma concentrations were demonstrated for the CoQ10 (NPN 02176955) formulation at 6 and 8 hr postdose ( p = .010 and p = .042, respectively). There were no significant differences between formulations with respect to the area under the curve, AUC(0-72 hr), or the maximum plasma concentration ( Cmax). Total CoQ10 ( Tmax) reached maximum plasma concentrations at 6.4 ± 2.5 hr after supplementation with CoQ10 (NPN 02176955), 8.0 ± 9.8 hr with CoQ10-P5P-PC, and 9.5 ± 9.3 hr with CoQ10 (DIN 02231736). The estimated elimination half-life ( t1/2) was 92.3 hr after a single oral dose of CoQ10-P5P-PC, 38.2 hr with CoQ10 (NPN 02176955), and 80.7 hr with CoQ10 (DIN 02231736). The results suggest that CoQ10 is available for a longer time in subjects' administered with CoQ10-P5P-PC in comparison with the other two formulations studied. There were no significant differences in adverse events, by severity, causality, or organ system. The CoQ10-P5P-PC formulation was found to be superior in the t1/2, and it may be suggested that fewer doses are required to maintain healthy circulatory CoQ10 levels. [ABSTRACT FROM AUTHOR]