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Objectives: To evaluate pharmacokinetics (PK), safety and tolerability of PEITC in Nutri-Jelly after single- and multiple-dose oral administration in healthy volunteers. Methods: This was an open-label, single- and multiple-dose study. Ten healthy subjects received a single dose of 40 mg PEITC in Nu...
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| 格式: | Theses and Dissertations |
| 語言: | Thai |
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จุฬาลงกรณ์มหาวิทยาลัย
2014
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| 主題: | |
| 在線閱讀: | https://digiverse.chula.ac.th/Info/item/dc:31462 |
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| 機構: | Chulalongkorn University |
| 語言: | Thai |
| 總結: | Objectives: To evaluate pharmacokinetics (PK), safety and tolerability of PEITC in Nutri-Jelly after single- and multiple-dose oral administration in healthy volunteers. Methods: This was an open-label, single- and multiple-dose study. Ten healthy subjects received a single dose of 40 mg PEITC in Nutri-Jelly and continued with this dose once daily for 5 days. Serial plasma samples at various times after administration on day 1 and day 5 were collected. Single-dose and multiple-dose pharmacokinetics were analyzed using non-compartmental analysis. Safety assessments included adverse events, physical examination, vital signs, electrocardiogram, clinical laboratory tests and subject interview. Results: After single administration, PEITC was rapidly absorbed with a mean ± SD time to peak plasma concentration (Tmax) of 2.65 ± 0.89 h. The average peak plasma concentration (Cmax) and AUC0-∞ were 357.36 ± 94.82 µg/L and 1,885.69 ± 474.23 µg/L⸱h, respectively. It was eliminated relatively fast with the average terminal half-life of 1.75 ± 0.93 h. The mean apparent volume of distribution and apparent total clearance were 1.13 ± 0.91 L/kg and 22.16 ± 4.31 L/h, respectively. After multiple-dose administration, the mean ± SD accumulation index was 1.005 ± 0.007. There was no serious adverse event reported and no clinically significant abnormality was found in any of the clinical and biochemical parameters. Conclusions: PEITC in Nutri-Jelly was rapidly absorbed and well-tolerated in healthy subjects, with mild adverse events after single- and multiple-dose oral administration. No significant accumulation was observed upon repeated doses for 5 days |
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