TCTR20201109001已完成未知
Pharmacokinetics and Bioequivalence (BE) Study of a New Branded Generic of Moxifloxacin Tablets among Healthy Volunteers
/A0 个研究点目标入组 30 人开始时间: 2020年11月9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
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •a)Healthy human adult literate subjects between 18-45 years of age (inclusive), having a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive).
- •b)Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to study start.
- •c)Subjects whose screening laboratory values, vital signs, ECG and chest X- ray are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- •d)Subjects whose SGPT/SGOT with in the reference range
- •e)Non-smokers or ex-smokers (Non-smokers for at least 3 months) or light smokers (less than I0 cigarettes per day for at least 3 months).
- •f)Informed consent given in written form according to section Il.3 of the protocol.
- •g)Female subjects with child-bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigators i.e. condoms, foams, jellies, diaphragm, intrauterine device (IUD).
排除标准
- •a)Have history of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •b)Have history of asthma, urticaria or other allergic type reactions after taking any medication.
- •c)Have history of hypersensitivity to Moxifloxacin and any other similar class of drugs or any of its excipients.
- •d)Have history of photosensitivity
- •e)Volunteer with significant alcohol dependence, alcohol abuse or drug abuse within past one year.
- •f)Moderate to heavy smoking (more than 10 cigarettes/day)
- •g)Consumption of tobacco products more than 4 packets/day.
- •h)Have difficulty in swallowing tablet/capsule
- •i)Any clinical illness identifies within 4 weeks before the start of the study
- •j)Subjects with QTc 2: 440ms to be excluded
- •k)Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the preceding 90 days prior to the start of the study.
- •l)Subject has donated blood in the preceding 90 days prior to the start of the study.
- •m)Subject who have positive urine drug screening, Alcohol breath analysis, HIV, VDRLIRPR, Hepatitis B & C tests.
- •n)Subject who have systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg
- •o)Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator
- •p)Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
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