Table 7.

Effect of 90-Day oral administration of test article on clinical chemistry parameters in male and female rats (n = 60/sex).

Parameter	Units	Group and Dose (mg/kg bw/day)
		G1 (0) n = 10	G2 (200) n = 10	G3 (400) n = 10	G4 (800) n = 10	G5 (0) n = 5	G6 (200) n = 5	G7 (400) n = 5	G8 (800) n = 5
Males
Na	mmol/L	140.2 ± 2.66	139.8 ± 2.15	140.7 ± 2.00	140.9 ± 2.60	142.8 ± 0.84	142.2 ± 0.84	142.6 ± 1.52	140.3 ± 3.59
K	mmol/L	5.563 ± 0.4536	5.097 ± 0.4437	5.093 ± 0.3864	5.030 ± 0.7194	5.324 ± 0.4663	5.236 ± 0.2078	5.322 ± 0.3023	5.353 ± 0.2716
6Cl	mmol/L	99.32 ± 2.433	98.88 ± 1.075	98.44 ± 1.661	99.30 ± 1.928	101.44 ± 0.688	101.28 ± 0.653	101.70 ± 1.693	99.98 ± 3.470
ALB	g/dL	3.86 ± 0.272	3.86 ± 0.217	4.06 ± 0.300	4.10 ± 0.236	3.62 ± 0.164	3.64 ± 0.152	3.52 ± 0.239	3.43 ± 0.126
AST	U/L	80.2 ± 9.94	76.1 ± 14.99	76.8 ± 5.24	83.4 ± 25.36	76.2 ± 16.15	71.2 ± 10.47	77.2 ± 25.05	63.3 ± 11.44
ALT	U/L	31.8 ± 6.09	33.3 ± 5.10	35.0 ± 4.90	34.3 ± 3.20	34.4 ± 1.52	36.2 ± 10.62	38.6 ± 6.88	32.8 ± 6.70
ALKP	U/L	90.8 ± 18.68	108.3 ± 17.99	96.0 ± 22.15	99.3 ± 6.33	63.6 ± 15.82	71.8 ± 12.81	79.2 ± 9.86	70.0 ± 12.08
BUN	mg/dL	11.5 ± 1.58	11.1 ± 1.20	12.4 ± 1.01	13.3 ± 2.58	11.6 ± 1.52	12.2 ± 1.92	12.6 ± 1.82	12.3 ± 0.96
CA	mg/dL	9.84 ± 0.320	9.84 ± 0.435	10.28 ± 0.563	9.98 ± 0.529	10.38 ± 0.277	10.34 ± 0.627	10.42 ± 0.259	10.40 ± 0.469
CHOL	mg/dL	72.2 ± 15.45	70.9 ± 10.90	72.9 ± 15.66	66.7 ± 13.30	99.6 ± 16.77	100.6 ± 24.82	104.4 ± 31.01	86.3 ± 28.69
CREAT	mg/dL	0.185 ± 0.0398	0.196 ± 0.0237	0.209 ± 0.0289	0.205 ± 0.0372	0.148 ± 0.0335	1.90 ± 0.0520	0.162 ± 0.0286	0.183 ± 0.0403
GLU	mg/dL	111.0 ± 24.07	103.6 ± 16.47	96.1 ± 12.14	102.1 ± 15.87	119.8 ± 9.86	120.8 ± 15.40	133.8 ± 17.25	120.0 ± 19.92
PHOS	mg/dL	6.67 ± 0.397	6.56 ± 0.479	6.72 ± 0.370	6.41 ± 0.384	5.94 ± 0.261	6.12 ± 0.487	6.02 ± 0.559	6.30 ± 0.245
TP	g/dL	6.21 ± 0.260	6.35 ± 0.398	6.68 ± 0.578	6.55 ± 0.360	6.70 ± 0.224	6.74 ± 0.313	6.68 ± 0.110	6.63 ± 0.443
TBIL	mg/dL	0.074 ± 0.0313	0.073 ± 0.0291	0.071 ± 0.0183	0.067 ± 0.0134	0.108 ± 0.0239	0.100 ± 0.0245	0.112 ± 0.0383	0.088 ± 0.0222
TRIG	mg/dL	132.1 ± 57.66	95.1 ± 32.10	83.2 ± 23.24	61.2 ± 18.84	116.2 ± 28.62	95.2 ± 28.37	129.4 ± 53.87	92.5 ± 35.72
SDH	U/L	4.18 ± 2.046a	4.07 ± 1.599	4.12 ± 1.987	3.37 ± 1.830b	6.62 ± 1.867	11.00 ± 6.605	9.14 ± 3.634	6.60 ± 3.017
TBA	μmol/L	26.0 ± 14.92	32.3 ± 19.73	52.7 ± 44.71	22.7 ± 10.29	16.7 ± 15.00	25.3 ± 12.11	73.7 ± 48.98	34.7 ± 23.66
GLOB	g/dL	2.35 ± 0.118	2.49 ± 0.321	2.62 ± 0.390	2.45 ± 0.207	3.08 ± 0.249	3.10 ± 0.187	3.16 ± 0.251	3.20 ± 0.346
Females
Na	mmol/L	139.6 ± 1.43	139.7 ± 1.83	140.1 ± 2.08	140.4 ± 2.51	140.2 ± 1.64	140.4 ± 1.82	141.6 ± 1.14	141.6 ± 1.52
K	mmol/L	4.589 ± 0.5311	4.669 ± 0.2851	4.593 ± 0.3708	4.488 ± 0.4549	4.702 ± 0.1758	5.024 ± 0.9254	4.658 ± 0.3737	4.992 ± 0.2335
Cl	mmol/L	99.10 ± 1.778	99.96 ± 1.773	99.08 ± 1.346	99.63 ± 2.680	100.54 ± 1.274	100.38 ± 2.780	101.04 ± 0.902	101.00 ± 1.739
ALB	g/dL	5.03 ± 0.359	4.71 ± 0.378	4.93 ± 0.359	4.99 ± 0.276	4.74 ± 0.207	4.04 ± 1.547	4.80 ± 0.292	4.74 ± 0.472
AST	U/L	63.9 ± 10.52	61.1 ± 6.85	70.6 ± 7.01	65.3 ± 7.23	86.4 ± 28.25	127.0 ± 84.03	128.0 ± 142.62	68.4 ± 9.76
ALT	U/L	30.4 ± 5.68	28.9 ± 3.07	32.8 ± 5.37	31.8 ± 4.49	47.2 ± 16.27	48.2 ± 35.29	40.6 ± 27.30	37.4 ± 5.59
ALKP	U/L	56.8 ± 21.13	60.4 ± 10.88	69.3 ± 19.52	67.6 ± 24.59	35.6 ± 11.10	102.6 ± 145.11	46.8 ± 19.70	40.4 ± 15.90
BUN	mg/dL	12.6 ± 1.90	13.6 ± 2.12	17.0 ± 2.45	15.1 ± 2.98	14.6 ± 4.72	15.0 ± 3.74	13.2 ± 2.39	16.2 ± 1.64
CA	mg/dL	10.63 ± 0.890	10.47 ± 0.460	10.63 ± 0.797	10.47 ± 0.510	10.50 ± 0.255	9.96 ± 1.122	10.48 ± 0.676	10.52 ± 0.164
CHOL	mg/dL	76.3 ± 21.45	84.8 ± 13.89	82.9 ± 17.31	90.9 ± 19.77	117.8 ± 22.44	92.4 ± 39.30	106.8 ± 32.07	109.0 ± 20.04
CREAT	mg/dL	0.259 ± 0.0357	0.264 ± 0.0241	0.270 ± 0.0383	0.276 ± 0.0555	0.254 ± 0.0607	0.230 ± 0.0543	0.232 ± 0.0383	0.274 ± 0.0385
GLU	mg/dL	108.8 ± 12.28	120.3 ± 14.50	127.8 ± 16.19	118.2 ± 19.43	130.4 ± 12.16	113.4 ± 36.29	123.0 ± 10.37	109.6 ± 7.99
PHOS	mg/dL	4.94 ± 0.773	4.90 ± 0.527	5.69 ± 0.479	5.87 ± 0.875	4.44 ± 0.577	5.00 ± 0.775	5.00 ± 0.529	5.62 ± 0.804
TP	g/dL	7.12 ± 0.349	6.88 ± 0.402	7.15 ± 0.528	7.37 ± 0.436	5.78 ± 0.455	6.98 ± 1.361	7.44 ± 0.662	7.62 ± 0.502
TBIL	mg/dL	0.082 ± 0.0239	0.083 ± 0.0226	0.114 ± 0.0406	0.094 ± 0.0375	0.118 ± 0.0370	0.142 ± 0.0687	0.108 ± 0.0179	0.114 ± 0.0279
TRIG	mg/dL	73.1 ± 23.96	77.1 ± 20.56	78.3 ± 20.91	71.9 ± 20.76	76.0 ± 20.87	82.2 ± 32.16	65.0 ± 6.44	79.2 ± 15.94
SDH	U/L	4.22 ± 1.624	4.04 ± 1.329	4.38 ± 1.873	4.24 ± 1.071	8.74 ± 3.314	15.60 ± 24.280	13.72 ± 18.836	5.50 ± 1.609
TBA	μmol/L	34.6 ± 20.95	32.9 ± 42.40	52.6 ± 52.00	79.7 ± 62.13	26.6 ± 13.24	40.3 ± 48.94	55.6 ± 70.69	56.4 ± 72.21
GLOB	g/dL	2.09 ± 0.338	2.17 ± 0.125	2.22 ± 0.274	2.38 ± 0.377	2.84 ± 0.321	2.94 ± 0.336	2.64 ± 0.541	2.88 ± 0.130

Values are mean ± standard deviation. ALB = albumin; ALKP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BUN = urea nitrogen; CA = calcium; CHOL = cholesterol; Cl = chloride; CREAT = creatinine; GLOB = globulin; GLU = glucose; K = potassium; NA = sodium; PHOS = inorganic phosphorous; SDH = sorbitol dehydrogenase; TBIL = total bilirubin; TP = total protein; TRIG = triglycerides.

^aN=8

^bN=9