A clinical evaluation to determine the safety, pharmacokinetics, and pharmacodynamics of an inositol-stabilized arginine silicate dietary supplement in healthy adult males

Figures & data

Table 1 Baseline characteristics of subjects (N=10)

Variable	Mean ± standard deviation Median (min–max)
N	10
Age	26.70±5.44
	26.00 (20–38)
BMI	26.03±3.01
	27.04 (21–30)
Ht (cm)	171.71±6.66
	173 (160–179)
Wt (kg)	76.77±10.33
	77.05 (62–95)
Race (White)%	100
Sex (male)%	100
Ethnicity (Hispanic)%	100

Abbreviations: min, minimum; max, maximum; BMI, body mass index; Ht, height, Wt, weight.

Table 2 Summary of PK parameters (with adjustment for body weight) for plasma l-arginine

Weight normalized†	Day 1	Day 14	P*
Plasma l-arginine
CMax	30.06±7.80	30.11±8.29	0.4922
	27.08 (22.90, 48.43)	26.41 (21.76, 46.17)
tMax	1.13±0.52	1.98±2.40	0.4961
	1.12 (0.47, 2.17)	1.08 (0.45, 8.17)
t1/2	15.93±9.55	13.43±6.60	0.6523
	11.03 (6.52, 34.13)	10.75 (7.16, 27.56)

Notes: These two PK test visits demonstrate the consistency in PK response to the product.

* Wilcoxon signed-rank test;

† weighted-adjusted PK parameters were calculated as PK × weight (kg)/70 kg.

Abbreviation: PK, pharmacokinetic.

Table 3 Summary of PK parameters (with adjustment for body weight) for serum silicon

Weight normalized†	Day 1	Day 14	P*
Serum silicon
CMax	2.99±0.63	2.87±0.55	0.2324
	2.72 (2.29, 4.29)	2.62 (2.35, 3.69)
tMax	2.44±2.05	3.31±2.54	0.2754
	2.09 (0.45, 6.52)	2.29 (1.09, 8.17)
t1/2	34.56±16.56	44.57±36.66	1.0000
	32.05 (17.21, 58.54)	32.40 (7.44, 114.17)

Notes: These two PK test visits demonstrate the consistency in PK response to the product.

* Wilcoxon signed-rank test;

† weighted-adjusted PK parameters were calculated as PK × weight (kg)/70 kg.

Abbreviation: PK, pharmacokinetic.

Figure 1 PK variables and their respective changes from mean serum arginine over time at each test visit, represented as mean value vs time.

Notes: Time is noted in hours. Visit 2 = Day 1 and Visit 3 = Day 14.
Abbreviation: PK, pharmacokinetic.

Figure 2 PK variables and their respective changes from mean serum silicon over time at each test visit, represented as mean value vs time.

Notes: Time is noted in hours. Visit 2 = Day 1 and Visit 3 = Day 14.
Abbreviation: PK, pharmacokinetic.