Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects
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 elimi nation 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 expos ure 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 simila rly safe in a cohort of healthy Chinese male and female participants, following administration under fasting and postprandial conditions.
Source: Clinical Pharmacology in Drug Development - Category: Drugs & Pharmacology Authors: Zhuan Yang,
Xiaolan Mi,
Qin Li,
Lu Chen,
Yan Zeng,
Peng Du,
Lin Liu,
Shijing Liu,
Chen Zeng,
Qian Zhang,
Yan Zhou,
Yun Xiong,
Na Li,
Qiuyuan Ze,
Jiyu Chen,
Yan He Tags: Original Article Source Type: research
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