Publication: Clinical Pharmacology in Drug Development
Abstract
This publication reports two independent crossover bioequivalence studies of a 30-mg nifedipine controlled-release tablet against a reference formulation in healthy Chinese subjects, conducted under fasting and fed conditions. Plasma nifedipine was measured by LC-MS and pharmacokinetic parameters were calculated by non-compartmental analysis using Phoenix WinNonlin. Reasonable bioequivalence was demonstrated between formulations under both conditions, with food co-administration reducing systemic nifedipine exposure by approximately 12%, and both products were similarly well tolerated with no serious adverse events. The results support the bioequivalence of the test and reference nifedipine controlled-release tablets under both fasting and fed conditions.
Author(s): Zhang H, Wang S, Wang H, Zhi T, Ren J, Wang Y, Yao Z, Zhang P, Ye N, Zhang R
Published: 2024 年 3 月 13 日
Phoenix WinNonlin: Two Studies, One Platform
Phoenix WinNonlin's non-compartmental analysis supported both the fasting and fed bioequivalence trials behind this nifedipine controlled-release study. Phoenix WinNonlin's results can flow directly into PK Submit for CDISC-compliant submission packages, within a Phoenix platform now available through Phoenix Cloud, combining cloud speed with AI-powered workflows.
