Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects

doi: 10.1002/cpdd.1329.

Online ahead of print.

Zhuan Yang^#^{1

2}, Xiaolan Mi^#³, Qin Li^#¹, Lu Chen¹, Yan Zeng¹, Peng Du¹, Lin Liu¹, Shijing Liu¹, Chen Zeng¹, Qian Zhang¹, Yan Zhou¹, Yun Xiong¹, Na Li¹, Qiuyuan Ze¹, Jiyu Chen^{1

2}, Yan He^{1

2}

Affiliations

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Zhuan Yang et al.

Clin Pharmacol Drug Dev.

2023.

doi: 10.1002/cpdd.1329.

Online ahead of print.

Authors

Affiliations

¹ Clinical Trials Center, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
² School of Pharmacy, Guizhou Medical University, Guiyang, China.
³ Tasly Academy, Tasly Holding Group Co., Ltd., Tianjin, 300410, China.

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Abstract

The objective of this research was to evaluate and compare the pharmacokinetic profiles and safety of lisinopril/hydrochlorothiazide (10 mg/12.5 mg) tablets in the test and reference formulations administered to participants in both fasting and postprandial states and to evaluate the bioequivalence of the 2 products in healthy Chinese volunteers. This study employed a single-center, randomized, open-label, single-dose dosing trial involving a cumulative 96 healthy adult participants (60 in the fasting group and 36 in the postprandial group). Each group comprised 2 sequence sets, and a 2-week washout period was implemented. There were no statistically significant differences in time to maximum concentration and terminal elimination half-life between the test and control groups under fasting and postprandial conditions (P > .05), and the 90% CIs for area under the plasma concentration-time curve and maximum plasma concentration were within the bioequivalence range of 80%-125%. Pharmacokinetic results indicate a large food effect for lisinopril, meaning that there is a loss of approximately 20%-25% of systemic exposure from fasting to postprandial administration for both preparations. The study demonstrated that a single oral dose of generic lisinopril/hydrochlorothiazide is bioequivalent to the reference product and well tolerated, with no significant adverse events observed, and that both products are similarly safe in a cohort of healthy Chinese male and female participants, following administration under fasting and postprandial conditions.

Keywords:

bioequivalence; lisinopril/hydrochlorothiazide; pharmacokinetics.

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