Pharmacokinetics of Terbinafine Hydrochloride Dispersible Tablets in Healthy Volunteers

WANG Haiying; JIANG Xuehua; ZOU Qin; SU Xu; CHEN Zhuo

doi:10.14009/j.issn.1672-2124.2020.07.015

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Pharmacokinetics of Terbinafine Hydrochloride Dispersible Tablets in Healthy Volunteers

更新时间：2022-10-08

- Pharmacokinetics of Terbinafine Hydrochloride Dispersible Tablets in Healthy Volunteers
- Vol. 20, Issue 7, Pages: 824-827(2020)
- 作者机构：
  
  1. 四川大学华西第二医院药物临床试验机构
  2. 四川大学华西药学院
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2020.07.015
  CLC： R969.1
- Published：2020，
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[1]王海英,蒋学华,邹琴,苏旭,陈卓.盐酸特比萘芬分散片在健康人体的药动学研究[J].中国医院用药评价与分析,2020,20(07):824-827.

WANG Haiying, JIANG Xuehua, ZOU Qin, et al. Pharmacokinetics of Terbinafine Hydrochloride Dispersible Tablets in Healthy Volunteers. [J]. 20(7):824-827(2020)
[1]王海英,蒋学华,邹琴,苏旭,陈卓.盐酸特比萘芬分散片在健康人体的药动学研究[J].中国医院用药评价与分析,2020,20(07):824-827. DOI： 10.14009/j.issn.1672-2124.2020.07.015.

WANG Haiying, JIANG Xuehua, ZOU Qin, et al. Pharmacokinetics of Terbinafine Hydrochloride Dispersible Tablets in Healthy Volunteers. [J]. 20(7):824-827(2020) DOI： 10.14009/j.issn.1672-2124.2020.07.015.

摘要

目的:探讨中国健康受试者单次口服盐酸特比萘芬分散片的药动学。方法:将24例健康男性受试者随机分为两组

分别单剂量口服给予受试制剂（盐酸特比萘芬分散片）或参比制剂（盐酸特比萘芬片）各1片

洗脱1周后

交叉给药

采用高效液相色谱法测定血药浓度

计算两者的主要药动学参数和相对生物利用度。结果:口服受试制剂或参比制剂后

两组受试者血浆中特比萘芬的主要药动学参数如下

max

分别为（1.545±0.999） h和（1.636±0.978） h

max

分别为（925.158±304.526） ng/ml和（907.765±355.11） ng/ml

以AUC

0→∞

计

受试制剂的相对生物利用度为108.2±27.6。结论:受试制剂与参比制剂在健康受试者体内具有生物等效性。

Abstract

OBJECTIVE: To investigate the pharmacokinetics of single oral Terbinafine dispersible tablets in healthy volunteers in China.METHODS: Twenty-four healthy male subjects were randomly divided into two groups

and the test preparation（ Terbinafine hydrochloride dispersible tablets） or the reference preparation（ Terbinafine hydrochloride tablets） was administered orally in a single dose.After elution for 1 week

cross-dose was performed.The blood drug concentration was determined by HPLC

and the main pharmacokinetic parameters and relative bioavailability of two drugs were calculated.RESULTS: After oral administration of the test or reference preparation

the main pharmacokinetic parameters of terbinafine in the plasma of the subjects were as follows

max

was（ 1.545 ±0.999） h and（ 1.636 ± 0.978） h

and C

max

was（ 925.158 ± 304.526） ng/ml and（ 907.765 ± 355.11） ng/ml

respectively.The relative bioavailability of the test preparation was 108.2 ± 27.6

which was calculated in AUC

0→∞

.CONCLUSIONS: The test preparation and reference preparation are bioequivalent in healthy volunteers.

关键词

盐酸特比萘芬高效液相色谱法生物等效性健康受试者药动学参数

Keywords

TerbinafineHPLCBioequivalenceHealthy volunteersPharmacokinetic parameters

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