Human Bioequivalence Study of Liposomal Amphotericin B for Injection
brief summary
A single-center, randomized, open-label, single-dose, two-period, double-crossover study to evaluate the bioequivalence of liposomal amphotericin B for injection (test product) manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd. compared to the reference product (AmBisome®) in healthy Chinese subjects. Secondary objectives include safety evaluation.
detailed description
The study involves 42 healthy subjects (male and female) aged 18-55 years. Subjects will be randomized into two groups (TR and RT) and receive either the test or reference product in period 1, followed by a 92-day washout period before crossing over to the other product in period 2. Blood samples will be collected at 25 time points for pharmacokinetic analysis.
official title
Single-Dose, Randomized, Open-Label, Two-Sequence, Two-Period, Double-Crossover, Bioequivalence Study of Liposomal Amphotericin B for Injection in Healthy Chinese Subjects