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临床试验/PACTR201302000483287
PACTR201302000483287已完成未知

EVALUATING PHARMACOKINETIC INTERACTIONS BETWEEN ARTEMISININ-BASED THERAPIES AND RIFAMPICIN-BASED TUBERCULOSIS TREATMENT IN AFRICAN PATIENTS

Infectious Diseases Institute, Makerer University College of Health Sciences0 个研究点目标入组 36 人开始时间: 2013年1月14日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
36

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 Year(s) 至 65 Year(s)(—)
性别
All

入选标准

  • ¿Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  • ¿Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • ¿Aged between 18 to 65 years, inclusive.
  • ¿Receiving TB-therapy containing rifampicin for at least 2 weeks

排除标准

  • ¿Hypersensitivity to any of the study drugs or excipients
  • ¿HIV infection
  • ¿Malaria infection at screening
  • ¿Serum hemoglobin < 8g/dL
  • ¿Elevations in serum levels of alanine transaminase, aspartate transaminase or creatinine above 3 times the upper limit of normal
  • ¿History of cardiac disease
  • ¿Diarrhea lasting greater than one week
  • ¿Use of herbal medications
  • ¿Use of potent inhibitors of CYP3A4 including grapefruit juice within 1 week of first dose of study drug and for the duration of the study
  • ¿Pregnant or lactating females

研究者

发起方
Infectious Diseases Institute, Makerer University College of Health Sciences

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