Table 4.
Summary of safety and adverse events of the modified-formula ECa 233 after single and multiple oral administration in different dosage regimens.
| Adverse events | 250 mg (n = 12) | 500 mg (n = 11) | Relation to medication | ||
|---|---|---|---|---|---|
| Single n/12 (%) | Multiple n/12 (%) | Single n/11 (%) | Multiple n/11 (%) | ||
| Drowsiness |
3/12 (25%) Mild-moderate |
3/12 (25%) Mild-severe |
3/11 (27.27%), Mild-severe |
1/11 (9.09%) Severe |
Unlikely |
| Gastrointestinal disorder | |||||
| Nausea | 0 |
1/12 (8.33%) Mild |
0 | 0 | Possible |
| Vomiting | 0 | 0 | 0 | 0 | – |
| Burning stomach | 0 | 0 | 0 | 0 | – |
| Abdominal discomfort | 0 |
2/12 (16.67%) Mild |
0 | 0 | Probable |
| Flatulence | 0 |
1/12 (8.33%) Mild |
1/11 (9.09%) Moderate |
1/11 (9.09%) Moderate |
Probable |
| Increased urinary frequency |
1/2 (8.33%) Mild |
1/12 (8.33%) Moderate |
0 | 0 |
1-possible 1-probable |
| Others | |||||
| Headache |
1/12 (8.33%) Moderate |
0 | 0 | 0 | Unlikely |
| Constipation | 0 | 0 |
1/11 (9.09%) Mild |
1/11 (9.09%) Mild-moderate |
Probable |