An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Comparative Bioavailability and Bioequivalence Study Vitamin D3 Liposomal Oral Solution 60000 IU per 5 mL Manufactured by Solistaa Pharmaceuticals Private Limited Puducherry India With Uprise D3 Syrup Vitamin D3 Oral Solution 60000 IU per 5mL Manufactured by Tirupati Medicare Ltd India Marketed By Alkem Laboratories Limited In Healthy Adult Human Subjects Under Fasting Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine the oral Bioavailability and bioequivalence of the test product Vitamin D3 Liposomal Oral Solution 60000 IU per 5 mL Manufactured by Solistaa Pharmaceuticals Private Limited Puducherry India With the reference product Uprise D3 Syrup Vitamin D3 Oral Solution 60000 IU per 5mL Manufactured by Tirupati Medicare Ltd India Marketed By Alkem Laboratories Limited in Healthy Adult Human Subjects Under Fasting Conditions
研究概览
简要总结
Enough volunteers shall be recruited in order to evaluate and start the study with at least 36 (27 Males and 09 Females) + 02 (stand by subject) healthy adult, human subjects.
As per the discretion of the Investigator, additionally stand-by I and stand-by II subjects will be included to ensure successful dosing of 36 subjects. (27 Males and 09 Females) Enough volunteers shall be recruited in order to evaluate and start the study with at least 36 (27 Males and 09 Females) + 02 (stand by subject) healthy adult, human subjects. As per the discretion of the Investigator, additionally stand-by I and stand-by II subjects will be included to ensure successful dosing of 36 subjects. (27 Males and 09 Females)
Demographic data, medical and medication history, physical examination, 12 lead ECG, hematology, biochemistry including Blood urea nitrogen (BUN), serology, urine routine analysis, Serum electrolytes test, Creatinine clearance, additionally for females serum pregnancy test, Hormone assay (FSH) will be done within 21 days and a chest X-ray within 06 months prior to check-in
In each period subjects will be housed in the clinical facility for at least -24.00 hours pre-dose to 48.00 hours post-dose with a washout period of at least 21 days from the successive dosing day.
Dosing will be done under yellow monochromatic light.
Blood pressure, radial pulse rate, body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour (within 75 minutes of before dosing) and at 01.00, 05.00, 08.00, 12.00, 24.00 and 36.00 hours (± 60 minutes) after completion of the dosing
Physical examination and vitals will be recorded before check-in, check-out (48.00 hours) for each period and at any time if necessary during the period of study
Seated blood pressure, radial pulse rate, body temperature and wellbeing status will be enquired and recorded before the collection of the ambulatory sample at (72.00, 96.00, 120.00 and 144.00) hours post dose. ECG will be recorded before check-out (48.00 hours) for each period or after any subject is withdrawn or dropped out from the study
The subject wellbeing record will be done at all the scheduled times for pre-dose and post dose vital signs recording.
Monitoring for adverse events will be done throughout the study period in clinical phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy adult human male and female subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.00 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 are 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 not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers Subjects who have the normal values of Vitamin D3 20 to 100 ng per ml prior to check in for each period Generally healthy as documented by gynaecological examination and breast examination period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check in for each period If the 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 subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non-childbearing potential defined as greater or equal to 01 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 of less than 1 percentage 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.
排除标准
- •Evidence of allergy or known hypersensitivity to Vitamin D3 or its inactive ingredients History of intake of Vitamin D3 supplement 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 illness Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products ie coffee tea chocolate 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 48.00 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 eg 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 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 Any blood donation or excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to the start of the 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 are likely to become pregnant during the course of the study.
结局指标
主要结局
To determine the oral Bioavailability and bioequivalence of the test product Vitamin D3 Liposomal Oral Solution 60000 IU per 5 mL Manufactured by Solistaa Pharmaceuticals Private Limited Puducherry India With the reference product Uprise D3 Syrup Vitamin D3 Oral Solution 60000 IU per 5mL Manufactured by Tirupati Medicare Ltd India Marketed By Alkem Laboratories Limited in Healthy Adult Human Subjects Under Fasting Conditions
时间窗: 22 Time Points | minus 24 00 Hrs minus 12 00 Hrs minus 06 00 Hrs 00 00 Hrs 00 25 Hrs 00 50 Hrs 01 00 Hrs 02 00 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 16 00 Hrs 20 00 Hrs 24 00 Hrs 36 00 Hrs 48 00 Hrs 72 00 Hrs 96 00 Hrs 120 00 Hrs and 144 00 Hrs
次要结局
- To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fasting conditions(22 Time Points)
研究者
Dr Pradeep T
Spinos Lifescience and research private limited