CTRI/2022/08/044837已完成未知
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two way Crossover Oral Comparative Pharmacokinetic Study Of Melotime Capsules (Melatonin SR Granules 11 Mg Equivalent To 5 Mg Melatonin) Manufactured By Nutriventia Limited, India With Melatonin Capsules 5 Mg Manufactured By Huanggang Saikang Pharmaceutical Co., Ltd, China In Healthy, Adult Human Subjects under Fasting Conditions. - Nil
Dr Shefali Thanawala0 个研究点目标入组 16 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
- 16
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
- •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 with all requirements of this study protocol as well as instructed by the study personnel.
- •Generally healthy as documented by gynaecological examination and breast examination (for female subjects ââ?¬â?? period I only).
- •Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH.
- •Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period.
- •If subject is female, currently not pregnant, not lactating, or not attempting to become pregnant for 4 weeks before the screening visit, throughout the duration of the study and 3 weeks after the subjectââ?¬•s last study-related visit (for eligible subjects only, if applicable), has a negative pregnancy test.
- •If male and sexually active, the subject is willing to commit to 2 acceptable methods of birth control for the duration of the study.
- •The subject and their partners are willing to use 2 types of contraception, one of which is a barrier method, such as the use of a condom throughout the study.
排除标准
- •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 Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarette and tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study.
- •Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to check-in and throughout the entire study.
- •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 each period.
- •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.
- •Subjects who have taken an unusual diet, for whatever reason (e.g. low salt) for 48.00 hours prior to check-in and throughout the study.
- •Any blood donation / excess blood loss within 90 days of check-in.
- •Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
- •Use of hormone replacement therapy for a Period of 06 months prior to dosing.
- •Female subjects demonstrating a positive pregnancy screen.
- •Female subjects who are currently lactating.
- •Females likely to become pregnant during conducting of the study.
研究者
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