JPRN-jRCTs061200015已完成4 期
Multicenter study to evaluate the influence for intestinal flora of multiple dose of Lascufloxacin hydrochloride
Chikumi Hiroki0 个研究点目标入组 20 人开始时间: 2020年9月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Healthy male volunteer
- •1) 20-45 years old healthy Japanese male
- •2) BMI of 18.5-25.0
- •3) Subject who was judged healthy by investigator at screening and hospital admission visit
- •4) Subject who do not have a tendency to constipate and have a habit of daily bowel movements
- •5) Subject who can defecate before administration of study drug
- •Pneumonia patient
- •1) 20 or above years old Japanese
- •2) Patients who were determined to administer Lascufloxacin hydrochloride by investigator
- •3) Patient with a clear infiltrative shadow on the chest X-ray or CT image taken within 48 hours before the start of study drug administration
- •4) Patient with symptoms suspected of respiratory infection
- •5) Patient who do not have a tendency to constipate and have a habit of daily bowel movements
- •6) Patient who can defecate before administration of study drug
排除标准
- •Healthy male volunteer
- •1) Subject with a history of hypersensitivity or serious adverse effects to quinolone antibiotics
- •2) Subject who have unsuitable medical history as a study subject or a history of abdominal surgery that may affect drug absorption
- •3) Subject who have drunk excessively or cannot keep drinking during the study period
- •4) Subject who received antibacterial drugs within 28 days before study drug administration or who schedule to administer antibacterial drugs during the study period
- •5) Subject who received lactic acid bacteria beverage within 7 days before study drug administration
- •6) Subject who have a positive immunoserologic test at the screening test
- •7) Subject who have participated in other clinical trials or clinical researches of unapproved drugs within 3 months before registration
- •Pneumonia patient
- •1) Patient with a history of hypersensitivity or serious adverse effects to quinolone antibiotics
- •2) Patient who are pregnant or nursing or who desire to become pregnant during the study period. Patient who is unwilling to agree to practice appropriate contraception during the study period
- •3) Lactating female patient
- •4) Patinet who have unsuitable medical history as a study subject or a history of abdominal surgery that may affect drug absorption
- •5) Patient who have drunk excessively or cannot keep drinking during the study period
- •6) Patient who received antibacterial drugs within 28 days before study drug administration or who schedule to administer antibacterial drugs during the study period
- •7) Subject who received lactic acid bacteria beverage within 7 days before study drug administration
- •8) Subject who have participated in other clinical trials or clinical researches of unapproved drugs within 3 months before registration
研究者
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