CTRI/2024/07/070710尚未招募Unknown
A Double-Blind, Randomized, Single Dose, Two-Treatment, Two-Way Crossover, Oral Bioavailability Study Of Investigational Product Containing Vitamin C in Healthy, Adult, Human Subjects Under Fasting Conditions. - NI
Molecules Biolab Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
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 and female Human participants of age between 18-45 years with a Body Mass Index range between 18.50 kg/m2 to 24.99 kg/m2.
- •2.Subject agrees avoid vitamin C containing medications and dietary supplements from screening until last visit.
- •3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
- •4.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
- •5.Subjects generally healthy as documented at screening considered by the physician or principal orclinical investigator.
- •6.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.
- •7.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •8.Willing to consume ova-lacto vegetarian diet.
- •9.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
- •10.Generally healthy as documented by gynecological examination and breast examination -for female subjects during Period-I check-in only.
- •11.Female subjects of childbearing potential;
- •a.Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or
- •b.Surgically sterile - bilateral tubal ligation
排除标准
- •1.Evidence of allergy or known hypersensitivity to Vitamin C or other related drugs or other related drugs.
- •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.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.
- •5.History of alcohol addiction or abuse.
- •6.Malabsorption syndrome that affects vitamin c metabolism.
- •7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than 100 per min ventricular rate.
- •8.Gastrointestinal bleeding in past three months.
- •9.Uncontrolled diabetes mellitus.
- •10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
- •11.Psychopathic disorder, lack of cooperation.
- •12.Chronic obstructive lung disease or active smoking - more than 2 cigarettes in the past 6 months
- •13.Taking more than 100 mg vitamin C daily within 2 weeks to screening.
- •14.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
- •15.Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
- •16.Subjects who taken any prescription medications, over the counter medicinal products, herbal medications within 14 days prior to study check in and throughout the study.
- •17.History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period.
- •18.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.
- •19.Subject who had participated in any other study within the 90 days of check-in.
研究者
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