CTRI/2017/10/010191已完成1 期
To evaluate the pharmacokinetic parameters of sildenafil citrate 18mg/ml solution of recipharm israel and viagra tablets 25mg of pfizer inc. in normal, healthy, adult, human male subjects under fasting conditions.
Vigorous Solutions Ltd0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
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
入选标准
- •1) Normal, healthy, adult, male human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2
- •2) Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within21days of check in.
- •3)Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
- •4) Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- •5) Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
- •6) Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •7) Willing to consume Ova lacto-vegetarian diet.
- •8) Willing to comply to all requirements of this study protocol as well as instructed by the study personnel.
排除标准
- •1) Evidence of allergy or known hypersensitivity to Sildenafil and its active metabolite, piperazine N-desmethylsildenafilor its inactive ingredients.
- •2) Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
- •3) Any major illness in the last three months or any significant ongoing chronic medical illness.
- •4) Renal or liver impairment.
- •5) Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •6) History of alcohol addiction or abuse.
- •7) Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study.
- •8) Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study.
- •9) Subjects should not take any over the counter medicinal products, herbal medications within 14 days prior to study check-in and throughout the study and any prescription medications within 07 days prior to study check-in and throughout the study.
- •10) An unusual or abnormal diet within 48.00 hours prior to study check-in of each period, for whatever reason e.g. because of fasting due to religious reasons.
- •11) Subject who had participated in any other study within the 90 days of check-in.
- •12) History of difficulty in swallowing.
- •13) History of difficulty in accessibility of veins.
- •14) Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of this study period.
- •15) Positive results for alcohol breath test prior to check-in of each period.
- •16) Any blood donation / excess blood loss within 90 days of check-in.
- •17) Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
- •18) Use of hormone replacement therapy for a Period of 06 months prior to dosing.
- •19) Any contraindication to blood sampling.
- •20) History of problem in swallowing.
研究者
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