Table 3.
Safety monitoring of healthy volunteers in the pharmacokinetic study. The data were presented as mean ± SD, n = 12. *Denotes to the statistical analysis between groups; †P < 0.05 and ††P < 0.01indicate significant differences from time 0 h within-group which analyzed using the Mann-Whitney U test.
| Clinical data | Time (h) | Sahastara (100 mg) | Sahastara (200 mg) | P-value* | Reference values |
|---|---|---|---|---|---|
| 0 | 86.33 ± 6.81 | 84.17 ± 5.97 | 0.450 | ||
| Glucose | 24 | 92.00 ± 6.37†† | 89.25 ± 6.51† | 0.487 | 74-106 mg/dL |
| 0 | 60.75 ± 14.96 | 61.08 ± 13.17 | 0.795 | ||
| High-density lipoprotein-cholesterol | 24 | 60.25 ± 13.29 | 59.58 ± 14.95 | 0.931 | 40-60 mg/dL |
| 0 | 217.08 ± 44.28 | 202.00 ± 27.63 | 0.506 | ||
| Total cholesterol | 24 | 226.58 ± 45.86 | 195.58 ± 26.83 | 0.060 | 0-200 mg/dL |
| 0 | 139.67 ± 39.98 | 128.50 ± 20.52 | 0.665 | ||
| Low-density lipoprotein-cholesterol | 24 | 145.00 ± 39.69 | 119.42 ± 19.92 | 0.126 | 0-100 mg/dL |
| 0 | 106.42 ± 75.05 | 83.42 ± 39.92 | 0.583 | ||
| Triglycerides | 24 | 105.08 ± 59.23 | 85.00 ± 39.24 | 0.453 | 0-150 mg/dL |
| 0 | 12.38 ± 2.47 | 11.58 ± 2.30 | 0.347 | ||
| Blood urea nitrogen | 24 | 12.00 ± 1.94 | 11.57 ± 1.68 | 0.887 | 7.0-18.0 mg/dL |
| 0 | 0.84 ± 0.17 | 0.79 ± 1.78 | 0.488 | ||
| Creatinine | 24 | 0.80 ± 0.17† | 0.75 ± 0.17 | 0.487 | 0.7-1.3 mg/dL |
| 0 | 8.00 ± 0.27 | 7.85 ± 0.35 | 0.257 | ||
| Total protein | 24 | 8.03 ± 0.35 | 8.03 ± 0.50 | 0.908 | 6.4-8.2 g/dL |
| 0 | 4.44 ± 0.37 | 4.29 ± 0.27 | 0.368 | ||
| Albumin | 24 | 4.53 ± 0.29 | 4.38 ± 0.33 | 0.336 | 3.4-5.0 g/dL |
| 0 | 3.54 ± 0.24 | 3.58 ± 0.35 | 1.000 | ||
| Globulin | 24 | 3.52 ± 0.36 | 3.67 ± 0.41 | 0.242 | 1.5-3.5 g/dL |
| 0 | 0.60 ± 0.28 | 0.49 ± 0.20 | 0.379 | ||
| Total bilirubin | 24 | 0.65 ± 0.21 | 0.54 ± 0.22 | 0.241 | 0.2-1.0 mg/dL |
| 0 | 0.17 ± 0.07 | 0.13 ± 0.05 | 0.188 | ||
| Direct bilirubin | 24 | 0.19 ± 0.07 | 0.14 ± 0.05 | 0.062 | 0.0-0.2 mg/dL |
| 0 | 19.08 ± 7.35 | 22.92 ± 15.25 | 0.602 | ||
| Aspartate transaminase (U/L) | 24 | 18.25 ± 7.26 | 19.67 ± 9.16 | 0.908 | 15-37 U/L |
| 0 | 37.17 ± 23.47 | 28.08 ± 8.66 | 0.309 | ||
| Alanine transaminase (U/L) | 24 | 35.50 ± 24.85 | 32.33 ± 19.78 | 0.707 | 30-65 U/L |
| 0 | 62.00 ± 12.48 | 63.17 ± 19.97 | 0.931 | ||
| Alkaline phosphatase (U/L) | 24 | 58.53 ± 10.48 | 57.41 ± 16.25 | 0.862 | 50-136 U/L |
| White blood cells | 0 | 5.79 ± 1.42 | 5.48 ± 1.18 | 0.525 | |
| 24 | 5.88 ± 1.78 | 5.86 ± 1.37 | 0.667 | 4.0-11.0 K/cumm | |
| Neutrophil | 0 | 52.20 ± 7.38 | 59.24 ± 5.81 | 0.019 | 45-75% |
| 24 | 51.11 ± 9.47 | 53.14 ± 11.36 | 0.667 | ||
| 0 | 37.91 ± 6.47 | 33.20 ± 6.18 | 0.069 | ||
| Lymphocyte | 24 | 39.82 ± 8.94 | 38.29 ± 10.76 | 0.805 | 20-45% |
| 0 | 4.79 ± 1.46 | 3.80 ± 1.51 | 0.106 | ||
| Monocyte | 24 | 4.80 ± 2.24 | 3.80 ± 1.26 | 0.388 | 2-10% |
| 0 | 4.53 ± 2.65 | 3.33 ± 2.09 | 0.194 | ||
| Eosinophil | 24 | 3.65 ± 1.76 | 4.40 ± 1.97 | 0.268 | 4-6% |
| 0 | 0.58 ± 0.24 | 0.43 ± 0.16 | 0.143 | ||
| Basophil | 24 | 0.63 ± 0.53 | 0.37 ± 0.30 | 0.204 | 0-1% |
| 0 | 4.80 ± 0.41 | 4.83 ± 0.45 | 0.954 | 4.50-6.00 × | |
| Red blood cell count | 24 | 4.93 ± 0.39 | 5.00 ± 0.59†† | 0.878 | 106/cumm |
| 0 | 13.18 ± 1.48 | 12.44 ± 0.95 | 0.354 | ||
| Hemoglobin | 24 | 13.62 ± 1.12 | 12.92 ± 0.97†† | 0.103 | 14.0-18.0 gm/dL |