CTRI/2022/03/041135已完成未知
AN OPEN-LABEL, BALANCED, RANDOMIZED, SINGLE-DOSE, TWO-TREATMENT, TWO-SEQUENCE, TWO-PERIOD, TWO-WAY CROSSOVER ORAL BIO AVAILABILITY STUDY OF COMPARING VITAMIN D3 (CHOLECALCIFEROL) NANO EMULSION SOFTGEL CAPSULES 50000 IU (1250 MCG) MANUFACTURED FOR AMITOJAS PVT LTD AND MANUFACTURED BY GELTEC PVT LTD, INDIA COMPARING WITH VITAMIN D3 (CHOLECALCIFEROL) CAPSULES 50000 IU (1250 MCG) MANUFACTURED BY VITANE PHARMACEUTICALS, INC, USA. IN HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING CONDITIONS.
Amitojas Wellness Pvt Ltd0 个研究点目标入组 36 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
- 36
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 kgperm2 to 29.99 kgperm2 according to the formula of BMI equal weight kg per height mX2 .
- •Vitamin D3 level greater 25ngperml.
- •Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21days of check in.
- •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.
- •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 XRay 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 vegetarian diet.
- •Willing to comply to all requirements of this study protocol as well as instructed by the study personnel.
- •Generally healthy as documented by gynecological examination and breast examination for female subjects 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 and 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 visitthroughout the duration of the study and 3 weeks after the subjects last study-related visit for eligible subjects only if applicable has a negative pregnancy test and is of non childbearing potential, defined as
- •Greater or equal 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 or is of
- •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 per year or is of
- •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.
- •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 Vitamin D or its inactive ingredients
- •History of intake of Vitamin D3 supplement
- •Subjects with hepatic encephalopathy cholestasis myasthenia, preexisting 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 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. tobacco containing products for at least 48.00 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 72.00 hours prior to check-in and throughout the entire study.
- •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.
- •Subject who had participated in any other study within the 90 days of check-in.
- •History of difficulty in swallowing.
- •History of difficulty in accessibility of veins.
- •Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamineAMP, 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.
- •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
相似试验
尚未招募
不适用
To evaluate bioavailability study of curcumin micro emulsion soft gel Capsules 500 mg with Curcumin c3 complex® 500 mg capsules in healthy, adult human subjects under Fasting conditions.CTRI/2022/03/041166Amitojas Wellness Pvt Ltd
尚未招募
不适用
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500 mg/25 mg Dispersible Tablets in Healthy subjects.CTRI/2018/11/016376Rena Exports
已完成
1 期
A clinical trial study to determine the oral bioavailability of curcuminoid capsules.CTRI/2021/05/033903Pharmabase SA24
已完成
不适用
Bioequivalence study of Cladribine 10 mg tablet in highly active relapsing multiple sclerosis patientsCTRI/2021/09/036201Hikma Pharmaceuticals40
尚未招募
4 期
To Evaluate Oral Bioavailability Efficacy of Co Enzyme Q10 100mg in Healthy Human Adult SubjectsCTRI/2022/10/046730Doctors Best Inc