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- W2361330385 abstract "Objective To study the tolerability,safety and pharmacokinetics of tratinterol hydrochloride tablets (SPFF) after single oral doses of 25 μg,50 μg and 100 μg in healthy Chinese volunteers. Methods This is a dose-escalation study,30 healthy volunteers were randomized to administer a single dose of tratinterol hydrochloride tablets at 25 μg,50 μg and 100 μg,respectively. Adverse event was nearly observed.the concentration of tratinterol hydrochloride in human plasma were determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated with WinNonLin 5.0.Results Thirty healthy volunteers have used SPFF tablets,two adverse events were judged by the investigator to be related to tratinterol hydrochloride tablets,which were mild in severity and abated without any treatment. There were no serious adverse events in this trial. The main pharmacokinetic parameters of tratinterol hydrochloride tablets after single oral doses of 25 μg,50 μg and 100 μg were as follows: Cmax were (12.2 ± 4.2),(20.0 ± 4.3),(48.6 ± 14.3) pg.mL-1; tmax were (1.1 ± 0.5),(1.8 ± 1.2),(1.3 ± 0.4) h;t1/2 were (19.9 ± 6.4),(18.0 ± 6.7),(17.7 ± 8.6) h; AUC0-tn were (80.5 ± 43.0) ,(116.7 ± 57.5),(215.7 ± 64.5) pg.h.mL-1; Ae were (1.7 ± 0.5) %,(2.1±0.8) %,(1.9 ± 0.3) %,respectively.Conclusion A singme oral doses of 25~100 μg tratinterol hydrochloride tablets were safe and well tolerated in Chinese healthy subjects. The process of tratinterol hydrochloride tablets in the dosage range of 25~100 μg fit linear dynamic feature." @default.
- W2361330385 created "2016-06-24" @default.
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- W2361330385 date "2008-01-01" @default.
- W2361330385 modified "2023-09-25" @default.
- W2361330385 title "Tolerability and pharmacokinetics of tratinterol hydrochloride tablets in healthy subjects after a single dose administration" @default.
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