To evaluate bio availability study of comparing Vitamin D3 (cholecalciferol) Nano emulsion soft gel capsules in healthy, adult human subjects under fasting conditions.
- Registration Number
- CTRI/2022/03/041135
- Lead Sponsor
- Amitojas Wellness Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method