A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults

Emergent BioSolutions3 个研究点分布在 1 个国家目标入组 154 人开始时间: 2012年12月最近更新: 2025年6月15日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Emergent BioSolutions
入组人数: 154
试验地点: 3
主要终点: Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA).

This study will be conducted in the United States (US) in 154 healthy male and female volunteer subjects ages 18 to 45.

The duration of study participation for each subject will be approximately 76 days (approximately 2.5 months)

详细描述

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. This is a randomized, open-label, Phase 2, multi-center trial to investigate the potential interactions of ciprofloxacin and BioThrax.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Be between 18 and 45 years of age, at the time of enrollment
•Be in good health as determined by the investigator from medical history and a physical examination.
•If a pre-menopausal female, must be using acceptable methods of birth control.
•Be willing and able to return for all follow-up visits and blood and urine collections for the duration of the trial
•Be willing and able to complete a web-enabled electronic diary and report concomitant medications, adverse events, and BioThrax reactogenicity events during the trial
•Be able to understand and communicate in English.

排除标准

•Prior immunization with anthrax vaccine or known exposure to anthrax organisms
•Intend to enlist in the military during the study.
•Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
•Plan to receive experimental products 30 days prior to study entry or at any time during the study
•Have received a live vaccine in the 30 days before study entry
•Plan to receive a live vaccine at any time during the study.
•Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates
•Have received immunosuppressive therapy (including systemic steroids) within 30 days prior to trial entry
•Have any other condition known to produce or be associated with immunosuppression
•Have received cytotoxic therapy in the previous 5 years
•A chronic condition that, in the opinion of the Investigator, would render vaccination unsafe or would interfere with trial evaluations or completion of the study.