CTRI/2022/03/041166尚未招募未知
AN OPEN LABEL, BALANCED, RANDOMIZED, SINGLE-DOSE, TWO-TREATMENT, TWO-SEQUENCE, TWO-PERIOD, TWO-WAY CROSSOVER ORAL BIOAVAILABILITY STUDY OF CURCUMIN MICRO EMULSION SOFT GEL CAPSULES 500 MG MANUFACTURED FOR AMITOJAS PVT LTD AND MANUFACTURED BY GELTEC PVT LTD, INDIA WITH CURCUMIN C3 COMPLEX® 500 MG CAPSULES MANUFACTURED BY DOCTORS BEST. INC, USA, IN HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING CONDITIONS.
Amitojas Wellness 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
- 未知
- 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
- Ba/be
入排标准
入选标准
- •1.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 (according to the
- •formula of BMI weight (kg) or[height (m)]2)
- •2.Subjects who have no evidence of underlying disease during screening and check-in
- •and whose screening is performed within 21 days of check in.
- •3.Subjects whose screening laboratory values are within normal limits or considered
- •by the physician or principal or 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 are defined as someone who has completely stopped
- •smoking for at least the past 03 months.
- •7.Willing to consume Ovo lacto vegetarian diet.
- •8.Willing to comply with all requirements of this study protocol as well as instructed
- •by the study personnel.
- •9.Generally healthy as documented by gynecological examination and breast
- •examination (for female subjects â?? period I only).
- •10.Female subjects within normal limits or clinically non-significant laboratory
- •evaluation results for FSH.
- •11.Females of childbearing potential must have a negative serum pregnancy test
- •performed within 21 days prior to initiation of the study and a negative urine
- •pregnancy test prior to check-in of each period.
- •12.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 subjectâ??s last study-related visit (for eligible subjects
- •only, if applicable), has a negative pregnancy test, and is of
- •non-childbearing potential, defined as:
- •1 year post-menopausal (no menstrual period for at least 12 consecutive
- •months without any other medical cause)
- •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
- •hysterectomy)
- •childbearing potential, willing to commit to using a consistent and acceptable
- •method of birth control as defined below for the duration of the study:
- •double barrier methods (condoms, cervical cap, diaphragm, and vaginal
- •contraceptive film with spermicide)
- •intrauterine device (IUD) with a low failure rate less than 1 percent per year
- •childbearing potential and not sexually active, willing to commit to using a
- •consistent and acceptable method of birth control as defined above for the
- •duration of the study, in the event the subject becomes sexually active.
- •13.If male and sexually active, the subject is willing to commit to 2 acceptable methods
- •of birth control for the duration of the study.
- •14.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
- •1.Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients.
- •2.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 ongoing chronic medical
- •3.Renal or liver impairment.
- •4.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.
- •5.History of alcohol addiction or abuse.
- •6.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 48.00 hours prior to check-in and throughout the entire study.
- •7.Consumption of alcohol and its products, grapefruit and/ or its juice and poppy
- •containing foods within 72.00 hours prior to check-in and throughout the entire study.
- •8.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.
- •9.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.
- •10.Subject who had participated in any other study within the 90 days of check-in.
- •11.History of difficulty in swallowing.
- •12.History of difficulty in accessibility of veins.
- •13.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.
- •14.Positive results for alcohol test prior to check-in of each period.
- •15.Any blood donation / excess blood loss within 90 days of check-in.
- •16.Ingestion of any hormonal agent at any time within 14 days prior to start of study
- •17.Use of hormone replacement therapy for a Period of 06 months prior to dosing.
- •18.Female subjects demonstrating a positive pregnancy screen.
- •19.Female subjects who are currently lactating.
- •20.Females likely to become pregnant during conducting of the study.
研究者
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