Publication: Clinical Pharmacology in Drug Development
Abstract
This publication assesses the pharmacokinetics, bioequivalence, and safety of a test formulation of bromocriptine mesylate tablets against a reference formulation in 40 healthy Chinese subjects under fed conditions, using a randomized, open-label, four-period, complete crossover design. Plasma concentrations were measured by UPLC-MS/MS, and pharmacokinetic parameters were derived using Phoenix WinNonlin, with maximum concentration assessed by reference-scaled average bioequivalence and AUC measures assessed by standard average bioequivalence. The fed-condition data met all bioequivalence criteria, and no serious adverse reactions were observed, indicating similar safety profiles between the two formulations. The results support the bioequivalence and comparable tolerability of the test bromocriptine mesylate tablet under fed conditions.
Author(s): Song H, Chen Y, Chen L, Yin X, Li H, Gan F
Published: 2025 年 9 月 29 日
Phoenix WinNonlin: Fed-Condition Bioequivalence
Phoenix WinNonlin handled both average and reference-scaled bioequivalence assessments in this bromocriptine study, meeting the criteria this fed-condition trial required. Phoenix WinNonlin is trusted by regulators worldwide, including the FDA, as part of a Phoenix platform relied on by 17 global regulatory agencies.
