Table 7.
Parameter | Units |
Dose (mg/kg/day) |
Historical control data1 |
|||
---|---|---|---|---|---|---|
0a | 500 | 1000 | 2000 | |||
Glucose | mg/dL | 156.00 ± 19.19 | 148.33 ± 26.93 | 144.48 ± 17.43 | 142.16 ± 22.08 | – |
Cholesterol | mg/dL | 74.55 ± 19.71 | 69.45 ± 12.70 | 69.98 ± 9.87 | 68.88 ± 15.24 | – |
Triglyceride | mg/dL | 23.82 ± 9.56 | 26.79 ± 9.68 | 24.49 ± 5.12 | 29.91 ± 19.65 | – |
Creatinine | mg/dL | 0.53 ± 0.09 | 0.55 ± 0.06 | 0.51 ± 0.08 | 0.53 ± 0.09 | – |
AST | U/L | 95.72 ± 14.46 | 89.34 ± 17.68 | 91.03 ± 15.30 | 98.37 ± 19.25 | – |
ALT | U/L | 24.12 ± 14.29 | 25.35 ± 8.45 | 26.83 ± 10.40 | 27.34 ± 8.88 | – |
Total protein | g/dL | 6.52 ± 0.42 | 6.45 ± 0.33 | 7.13 ± 0.26* | 6.61 ± 0.18 | 5.72 ∼ 7.98 |
Total bilirubin | mg/dL | 0.063 ± 0.015 | 0.063 ± 0.005 | 0.067 ± 0.006 | 0.076 ± 0.027 | – |
gamma-glutamyl transferase | U/L | NA | NA | NA | NA | – |
Alkaline phosphatase | U/L | 114.80 ± 34.33 | 125.16 ± 30.6* | 118.77 ± 25.35 | 132.35 ± 38.18* | 58.16 ∼ 176.63 |
Amylase | U/L | 997.30 ± 156.20 | 1022.50 ± 178.40 | 1062.50 ± 160.30 | 1005.30 ± 170.50 | – |
Albumin | g/dL | 4.65 ± 0.27 | 4.82 ± 0.37 | 4.92 ± 0.56 | 4.58 ± 0.37 | – |
Creatine kinase | U/L | 389.50 ± 143.71 | 354.16 ± 128.63 | 351.93 ± 98.37 | 393.69 ± 163.03 | – |
Sodium | mmol/L | 140.25 ± 1.65 | 148.15 ± 1.20* | 147.20 ± 2.26* | 142.18 ± 1.66 | 132.51 ∼ 151.47 |
Potassium | mmol/L | 3.982 ± 0.318 | 3.945 ± 0.250 | 4.025 ± 0.332 | 4.106 ± 0.217 | – |
Phosphorus | mg/dL | 5.84 ± 0.69 | 6.02 ± 0.77 | 5.82 ± 0.93 | 5.96 ± 0.65 | – |
Calcium | mg/dL | 10.40 ± 0.35 | 10.45 ± 0.75 | 10.05 ± 0.64 | 10.36 ± 0.35 | – |
Chloride | mmol/L | 105.66 ± 1.68 | 104.75 ± 1.33 | 105.22 ± 2.70 | 105.20 ± 1.80 | – |
BUN | mg/dL | 15.90 ± 2.06 | 16.10 ± 1.63 | 16.60 ± 1.86 | 16.72 ± 1.70 | – |
aVehicle control: Sterile water for injection (WFI).
NA = No data available (Due to below detection limit).
1Historical control data: Level Biotechnology Inc., Preclinical Testing Center.
Values are mean ± SD for 12 rats in each group unless mentioned.
*p < 0.05.
AST = aspartate aminotransferase; ALT = alanine aminotransferase; BUN = blood urea nitrogen.