Bioequivalence study of vonoprazan fumarate tablets in healthy Chinese subjects: a randomized, open-label, two-period crossover trial.

Objectives: To evaluate the bioequivalence and safety of a test formulation (Vonoprazan Fumarate Tablets, 20 mg, T) compared with the reference product (Takecab®, 20 mg, R) in healthy Chinese subjects under both fasting and fed conditions. Methods: This was a single-center, randomized, open-label, single-dose, two-sequence, two-period, crossover study. Seventy-two healthy subjects were enrolled and assigned to either a fasting (n = 32) or a fed (n = 40) cohort. In each period, subjects received a single dose of either the test (T) or reference (R) formulation, separated by a 5-day washout period before crossing over to the alternate treatment. Plasma vonoprazan concentrations were quantified using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. Pharmacokinetic parameters were calculated using non-compartmental analysis. Bioequivalence was assessed by determining whether the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs, T/R) of C Results: Seventy of the 72 enrolled subjects completed the study. Under fasting conditions, the GMRs (90% CIs) for C Conclusion: The test formulation of vonoprazan fumarate is bioequivalent to the reference formulation and is well tolerated in healthy Chinese subjects under fasting and fed conditions. Clinical trial registration: https://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml, identifier CTR20233597.