title: The effect of food on the pharmacokinetic properties and bioequivalence of two formulations of pitavastatin calcium in healthy Chinese male subjects.
abstract: 1. Pitavastatin is an effective treatment for primary hyperlipidemia and mixed dyslipidemia. The aim of the present study was to investigate the effect of food on the pharmacokinetic properties and bioequivalence of the original, branded, formulation of pitavastatin calcium and a new generic formulation in healthy Chinese male subjects under fasting and fed conditions. 2. Under fasting and fed conditions, 90% CIs of the geometric mean of generic/branded AUC0-48 h ratios were 92.2-102.4%, 93.1-104.5%, the ratios of ln(AUC0-∞) were 92.6-103.7%, 93.2-103.5%, and ln(Cmax) ratios were 90.7-110.3%, 84.7-100.8%, respectively. The generic and branded formulations were bioequivalent in terms of rate and extent of absorption under both the conditions. The average values of AUC0-48 h, AUC0-∞ and Cmax decreased noticeably following a high-fat breakfast. Values for AUC0-48 h were 87.69% and 83.7%, values for AUC0-∞ were 87.5% and 84.6%, and values for Cmax were 45.0% and 50.4% in subjects given the generic and branded preparations, respectively. The absorption of pitavastatin calcium tablets was delayed following a high-fat meal, with Tmax increasing by up to 2.43-fold. 3. Both formulations were generally well tolerated, with no serious adverse reactions reported. The newly developed generic formulation may provide a reliable alternative to the branded tablets for patients with primary hyperlipidemia or mixed dyslipidemia.
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Dewei
authors.initials: D
authors.lastname: Shang
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Shuhua
authors.initials: S
authors.lastname: Deng
authors.affiliation: b HaiNan HuaLon Pharmaceutical Co., Ltd. , Hainan , PR China.
authors.forename: Zhenhong
authors.initials: Z
authors.lastname: Yao
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Zhanzhang
authors.initials: Z
authors.lastname: Wang
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Xiaojia
authors.initials: X
authors.lastname: Ni
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Ming
authors.initials: M
authors.lastname: Zhang
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Jinqing
authors.initials: J
authors.lastname: Hu
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Haoyang
authors.initials: H
authors.lastname: Lu
authors.affiliation: b HaiNan HuaLon Pharmaceutical Co., Ltd. , Hainan , PR China.
authors.forename: Xiuqing
authors.initials: X
authors.lastname: Zhu
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Wencan
authors.initials: W
authors.lastname: Huang
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Chang
authors.initials: C
authors.lastname: Qiu
authors.affiliation: a Institution of National Drug Clinical Trials of Guangzhou Brain Hospital (Guangzhou Huiai Hospital, The Affiliated Brain Hospital of Guangzhou Medical University) , Guangzhou , China and.
authors.forename: Yuguan
authors.initials: Y
authors.lastname: Wen
mesh_terms: D000328:Adult; D044466:Asian People; D002626:Chemistry, Pharmaceutical; D005502:Food; D006262:Health; D006801:Humans; D008297:Male; D011804:Quinolines / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D011804:Quinolines; C108475:pitavastatin
keywords: Bioequivalent; food effect; pharmacokinetics; pitavastatin