Comparative Bioequivalence and Food Effect of Two Formulations of 30‐mg Nifedipine Controlled‐Release Tablets in Healthy Chinese Adults

生物等效性 硝苯地平 医学 药代动力学 药理学 交叉研究 不利影响 二氢吡啶 药品 内科学 安慰剂 替代医学 病理
作者
Huizi Zhang,Siyang Wang,Hongxia Wang,Tingting Zhi,Jian Ren,Sheng Wang,Zhiqing Yao,Pan Zhang,Naobei Ye,Ruiqin Zhang
出处
期刊:Clinical pharmacology in drug development [Wiley]
卷期号:13 (5): 499-505 被引量:1
标识
DOI:10.1002/cpdd.1396
摘要

Abstract Nifedipine is a potent antihypertensive medication classified as a dihydropyridine calcium channel blocker. The objective of this trial was to assess the bioequivalence of a 30‐mg nifedipine controlled‐release tablet and a reference drug in a cohort of healthy Chinese individuals. Two independent open‐label, randomized, single‐dose, crossover studies were conducted, 1 under fasting conditions (N = 44, with 1 participant dropping out midway) and the other under fed conditions (N = 44, with 4 participants dropping out midway). Plasma concentrations of nifedipine were determined using liquid chromatography‐mass spectrometry, and pharmacokinetic (PK) parameters were calculated using noncompartmental analysis with Phoenix WinNonlin 8.0 software. In both fasting and fed studies, reasonable bioequivalence was observed for the PK parameters of both the test product and the reference drug. A good safety profile was demonstrated for both the test product and reference drug, with no serious adverse events reported, and both were similarly well tolerated. An important observation with food coadministration was that systemic exposure to nifedipine (based on area under the curve, AUC 0‐∞ ) was reduced by approximately 12%. The bioequivalence of the test product and reference drug under fasting/fed conditions in healthy subjects in China was demonstrated by the study results.
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