An Open-label, Randomised, Single-dose, Two-period Cross-over Study to Evaluate Bioequivalence of GR37547 Ciprofloxacin 500 mg Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Participants Under Fasting Conditions

This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions. Subjects will receive Treatment A (GR37547 tablet) and Treatment B (ciprofloxacin reference tablet) in crossover manner, separated by a washout period of at least 7 days and not more than 14 days. The total duration of study for each subject will be approximately 5-7 weeks. This study will enroll approximately 26 healthy adult subjects at a single center.本项两周期交叉试验旨在评估受试制剂GR37547（环丙沙星（ciprofloxacin）500mg片剂）与参比制剂环丙沙星500mg片剂在健康成年受试者空腹状态下的生物等效性。受试者将以交叉给药方式接受试验A（GR37547片剂）与试验B（环丙沙星参比片剂），两次给药间隔设置至少7天且不超过14天的洗脱期。每位受试者的总研究周期约为5至7周。本试验将在单中心招募约26名健康成年受试者。

搜集汇总

背景与挑战

背景概述

该数据集描述了一项Phase 1开放标签、随机、单剂量、双周期交叉研究，旨在评估GR37547 Ciprofloxacin 500 mg片剂与参考产品在健康成人空腹条件下的生物等效性。研究涉及26名健康成人受试者，在南非单一中心进行，数据仅在安全研究环境中可用，由葛兰素史克赞助。