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

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.