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临床试验/IRCT20130626013776N102
IRCT20130626013776N102尚未招募未知

Comparison of the relative bioavailability of Aanidarman and Bayer formulations of ciprofloxacin 500 mg tablets in 24 healthy adult volunteers under fasting conditionss

Aanidarman Pharmaceuticals0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 55 years(—)
性别
All

入选标准

  • 18-55 years of age.
  • The subject is able and willing to provide signed informed consent.
  • The subject is available for the entire study period.
  • Willing to adhere to protocol requirements as evidenced by written informed consent.
  • The subject has a stable residence and telephone.
  • Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.

排除标准

  • History of allergy or sensitivity to ciprofloxacin.
  • History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
  • Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
  • Presence of gastrointestinal disease or history of malabsorption within the last year.
  • History of medical disorders occurring within the last year that required hospitalization or medication.
  • Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
  • Receipt of any drug as part of a research study within 30 days prior to the present study.
  • Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.

研究者

发起方
Aanidarman Pharmaceuticals

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Bioequivalence study of ciprofloxacin 500 mg tablets | 临床试验