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首页> 外文期刊>The American journal of drug and alcohol abuse >Urine and plasma pharmacokinetics of lofexidine after oral delivery in opiate-dependent patients.
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Urine and plasma pharmacokinetics of lofexidine after oral delivery in opiate-dependent patients.

机译：鸦片依赖性患者口服分娩后洛氟丁定的尿液和血浆药代动力学。

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OBJECTIVES: The objective of this study was to investigate lofexidine urine and plasma pharmacokinetics using three different dosing regimens in opioid dependent subjects. To date, there have been no published studies on lofexidine appearance and excretion in urine of opioid dependent subjects. METHODS: Subjects were stabilized with 100 mg morphine sulphate on days 3-8 of the study. The dosing regimens of lofexidine hydrochloride were .8 mg twice a day (BID), 1.2 mg BID, or .8 mg three times a day (TID) on days 9 through 16 of the study. Plasma and urine samples were collected at appropriate time points. Area under the concentration-time curve (AUC), maximum concentration in plasma (C(max)), time when maximum concentration was reached (T(max)) and fraction excreted unchanged in urine (Fe) were calculated. RESULTS: The average half-life obtained from all profiles was 12.1 +/- 6.3 hr. Steady-state (SS) was reached by study day 15. The plasma pharmacokinetic parameters for 1.2 mg BID and .8 mg TID dosing regimens did not seem to be different at steady state (day 15). T(max) was not statistically significantly different across dosing regimens. Fe values ranged between .01% and 34% with high variability within the same dosing regimen. For the total dose of 2.4 mg/day the two dosing regimens that were evaluated, namely 1.2 mg BID and .8 mg TID, did not show a significant statistical difference in plasma and urine pharmacokinetic parameters. CONCLUSION: Although preliminary due to the limited number of subjects, these findings are the first to document lofexidine urine pharmacokinetics in opiate addicts using a highly sensitive liquid chromatography tandem mass spectrometric analysis.
机译：目的：本研究的目的是在阿片类药物依赖的受试者中使用三种不同的给药方案研究洛非替丁的尿液和血浆药代动力学。迄今为止，尚未有关于阿片类药物依赖性受试者尿液中洛美定的出现和排泄的公开研究。方法：在研究的第3-8天，用100 mg硫酸吗啡稳定受试者。在研究的第9天至第16天，盐酸洛氟西定的给药方案为每日两次（BID）为0.8毫克，每日两次BID为1.2毫克或每天3次为0.8毫克（TID）。在适当的时间点收集血浆和尿液样本。计算浓度-时间曲线（AUC）下的面积，血浆中的最大浓度（C（max）），达到最大浓度的时间（T（max））和尿液中未改变排泄率（Fe）。结果：从所有配置文件中获得的平均半衰期为12.1 +/- 6.3小时。在研究第15天时达到稳态（SS）。稳态时（第15天）的1.2 mg BID和.8 mg TID给药方案的血浆药代动力学参数似乎没有变化。不同给药方案的T（max）在统计学上无显着差异。 Fe值范围在0.01％到34％之间，并且在相同的给药方案中变化很大。对于2.4 mg /天的总剂量，所评估的两种给药方案（即1.2 mg BID和.8 mg TID）在血浆和尿液药代动力学参数上没有显示出显着的统计学差异。结论：尽管由于受试者人数有限而初步，但这些发现是第一个使用高灵敏度液相色谱串联质谱分析法记录鸦片剂成瘾者鸦片类药物药代动力学的。

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