CTRI/2020/04/024700已完成未知
Single dose oral bioavailability pilot study of two test formulations ofFlavoxate XR Tablet 600 mg, once a day (T1) and Flavoxate XR Tablet800 mg, once a day (T2) and reference formulation of Flavoxate Tablet200 mg, thrice a day (R) in healthy adult male subjects under fastingconditions.
Martin Harris Laboratory Limited0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive.
- •Selection of subjects for the study will be done based on assessment against the inclusion and exclusion criteria mentioned in the protocol.
- •Subjects from the pool of healthy volunteers who were screened within 28 days prior to the
- •first dosing day will be considered as potential participants in the study.
- •Subjects must be enrolled in the study only after providing written informed consent.
排除标准
- •Volunteers must not be enrolled in the study if they meet any one of the following criteria:
- •1) History of allergic responses to Flavoxate, or other related drugs, or any of its
- •formulation ingredients.
- •2) Have significant diseases or clinically significant abnormal findings during screening,
- •[medical history, physical examination, laboratory evaluations, ECG, chest X-ray
- •recording and ophthalmic examination (tonometry)].
- •3) Any disease or condition like diabetes, psychosis or others which might compromise the
- •haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central
- •nervous system or any other body system.
- •4) History or presence of bronchial asthma.
- •5) Use of any hormone replacement therapy within 3 months prior to the first dose of study
- •medication.
- •6) A depot injection or implant of any drug within 3 months prior to the first dose of study
- •medication.
- •7) Use of enzyme-modifying drugs within 30 days prior to the first dose of study
- •medication.
- •8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •9) Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or
- •those who cannot refrain from smoking during the study period.
- •10) History of difficulty with donating blood or difficulty in accessibility of veins.
- •11) A positive hepatitis screen (includes subtypes B & C).
- •12) A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- •13) Volunteer who have received a known Investigational drug within ten elimination half
- •life of the administered drug prior to the first dose of study medication or have donated
- •blood or loss of blood 50 mL to 100 mL within 30 days or 101 mL to 200 mL within 60
- •days or >200 mL within 90 days (excluding volume drawn at screening for this study)
- •prior to first dose of study medication, whichever is greater.
- •14) History of difficulty in swallowing or of any gastrointestinal disease which could affect
- •drug absorption.
- •15) Intolerance to venipuncture.
- •16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the
- •Principal Investigator or Sub-Investigator, could contraindicate the volunteerââ?¬•s
- •participation in this study.
- •17) Institutionalized volunteer.
- •18) History of galactose intolerance, the Lapp Lactose deficiency and glucose galactose
- •malabsorption.
研究者
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