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Arzneimittelforschung 2007; 57(8): 522-525
DOI: 10.1055/s-0031-1296642
CNS-active Drugs · Hypnotics · Psychotropics · Sedatives
Editio Cantor Verlag Aulendorf (Germany)

Bioequivalence of Two Tablet Formulations of Helicidum Adminstered in Single Dose to Healthy Chinese Volunteers

Kun Hao
1   Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University Nanjing, The People’s Republic of China
,
Yan guang Cao
1   Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University Nanjing, The People’s Republic of China
,
Ya nan Zhao
2   Clinical Pharmacology Base, Yijishan Hospital, Wannan Medical College, Wuhu, The People’s Republic of China
,
Guo guang Mao
2   Clinical Pharmacology Base, Yijishan Hospital, Wannan Medical College, Wuhu, The People’s Republic of China
,
Xiao quan Liu
1   Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University Nanjing, The People’s Republic of China
,
Guang ji Wang
1   Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University Nanjing, The People’s Republic of China
› Author Affiliations
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Publication History

Publication Date:
21 December 2011 (online)

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Abstract

In this 2 × 2, randomized, crossover bioequivalence study, two tablet preparations of helicidum were compared in 20 healthy Chinese male subjects. The drug was given in a single dose of three tablets (75 mg) and blood samples were withdrawn during 12 h after drug administration. Helicidum was separated and analyzed using a validated liquid chromatography-mass spectrum method. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The primary calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two preparations, using various statistical methods.

The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90 % confidence intervals fell within the acceptable range (80-120 %) for bioequivalence. Based on these statistical inferences it can be concluded that the two tablet preparations of helicidum are likely to be bioequivalent.

Key words

Helicid hilagirica Beed - Helicidum, bioequivalence, pharmacokinetics