Summary of results from dose proportionality assessment of a single ascending dose study in rats receiving an i.v. bolus dose of tanshinol solution (2–200 mg/kg)
Critical intervals were 0.952–1.048 for the systemic exposure data of tanshinol from the single ascending dose study of rat given an i.v. bolus dose of tanshinol (2–200 mg/kg). The term r denotes the correlation coefficient. Correlations were statistically significant with a P < 0.05. The term ”linear” was concluded statistically if the 90% confidence interval (90% CI) for slope was contained completely within the critical interval; inconclusive was concluded statistically if the 90% CI lay partly within the critical interval; nonlinear was concluded statistically if the 90% CI was entirely outside the critical interval.
| PK Parameter | r | P | Slope (90% CI) | Conclusion |
|---|---|---|---|---|
| Plasma | ||||
| C5min | 0.998 | 2.31 × 10−16 | 0.989 (0.955–1.023) | Linear |
| AUC0–∞ | 0.997 | 2.57 × 10−16 | 1.038 (1.002–1.075) | Inconclusive |
| Kidney | ||||
| C5min | 0.985 | 2.73 × 10−11 | 0.978 (0.893–1.062) | Inconclusive |
| AUC0–∞ | 0.990 | 1.66 × 10−12 | 1.070 (0.996–1.144) | Inconclusive |