Bioequivalence study of vonoprazan fumarate tablets in healthy Chinese subjects: a randomized, open-label, two-period crossover trial
Abstract
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 max , AUC 0-t , and AUC 0 ‐ ∞ fell within the predefined range of 80%–125%. Results Seventy of the 72 enrolled subjects completed the study. Under fasting conditions, the GMRs (90% CIs) for C max , AUC 0-t , and AUC 0 ‐ ∞ were 95.45% (88.96%–102.41%), 98.15% (93.93%–102.56%), and 98.53% (94.41%–102.83%), respectively. Under fed conditions, the corresponding values were 105.00% (94.35%–116.85%) for C max , 101.96% (98.10%–105.97%) for AUC 0-t , and 102.31% (98.58%–106.17%) for AUC 0…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 72 participants or records.
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