An Open Label Balanced Randomized Single Dose Three Treatment Three Sequence Three Period Three Way Crossover Oral Pharmacokinetic Study Comparing Capsaicinoids 50 Mg And 25 Mg Capsules Manufactured By Nutriventia Limited India With Cayenne 250 Mg Capsules Manufactured By Now Foods USA In Healthy Adult Human Subjects Under Fasting Conditions

Dr Shefali Thanawala0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•Normal healthy adult human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during
•screening and check-in and whose screening is performed within 21 days of check in
•Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical
•significance
•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
•Generally healthy as documented by 12-lead electrocardiogram (ECG) X-Ray and clinical laboratory
•assessments
•Non-smokers or ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months
•Willing to consume ovo lacto vegetarian diet
•Willing to comply all requirements for this study protocol as well as instructed by the study personnel

•Evidence of allergy or known hypersensitivity to Melatonin or its
•inactive ingredients
•Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and
•pre-existing gallbladder disease.
•Any major illness in the last three months or any significant on going
•chronic medical illness.
•Renal or liver impairment.
•Any disease or condition which might compromise the hemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system diabetes psychosis or any other body system
•History of alcohol addiction or abuse
•Consumption of caffeine and or Xanthiine containing products
•cigarette and tobacco containing products for at least 24.00 hours
•prior to check-in and throughout the entire study
•Positive results for alcohol test prior to check-in of each period.
•Subjects who have taken any prescription medications within 14
•days prior to study check-in and throughout the study and any over
•the counter medicinal products, herbal medications within 07 days
•prior to check-in and throughout the study

发起方

Dr Shefali Thanawala