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To evaluate the effects of itraconazole capsules on the pharmacokinetics of a single oral dose of ADC189 and its metabolite ADC189-I07 in Chinese healthy subjects, and to assess the safety of their co-administration.
This was a single-center, open-label, non-randomized, two-period, fixed-sequence trial, using itraconazole as an inhibitor of cytochrome P450 3A4 (CYP3A4), P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Analyze the impact of repeated administration of itraconazole capsules on the pharmacokinetic characteristics of ADC189 and its major metabolite ADC189-I07.
After co-administration of ADC189 with itraconazole, there was no difference in the maximum plasma concentration (Cmax) of the active metabolite ADC189-I07 in plasma compares with ADC189 alone; the geometric mean ratio was 106.64%, with a 90% confidence interval (CI) of 84.12%-135.16%. The area under the curve (AUC0-t) and AUC0-∞ increased by approximately 42.00% and 47.00%, respectively, with geometric mean ratios and 90% confidence intervals of 142.48% (120.84%-167.98%) and 147.25% (123.95%-174.91%), respectively. The 90% CIs for all three parameters did not fall entirely within the no-effect boundary of 80.00%-125.00%. The median time to peak drug concentration (tmax) of ADC189-I07 was 4.00 (3.00-4.00) after administration alone and 4.00 (3.00-12.00) h after co-administration; non-parametric tests showed no statistically significant difference in tmax (P>0.05). All adverse events (AEs) during the trial were grade 1 or 2, resolved spontaneously, and the safety risk was controllable.
When ADC189 tablets are used clinically with a strong CYP3A4 inhibitor, no dosage adjustment is required for concomitant use.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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