CTRI/2017/07/008953尚未招募未知
An open label, randomized, single dose, two-treatment, two sequence, two-period, two way crossover, oral bioavailability study of liposomal vitamin c 5ml/1000mg (test) of curesupport, b.v.wehryweg 27, valkenburg a/d geul, and non liposomal vitamin c 5ml/1000mg (reference) of curesupport, b.v.wehryweg 27, valkenburg a/d geul in healthy, adult, human subjects under fasting conditions.
CureSupport0 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
- Interventional
入排标准
入选标准
- •1. Normal, healthy, adult, male and female human subjects of age between 18-45 years
- •with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 30.00 kg/m2
- •2. Subject agrees avoid Curcumin containing medications and dietary supplements
- •from screening until last visit.
- •3. Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
- •4. Subjects who have no evidence of underlying disease during screening and check-in
- •and whose screening is performed within 29 days of check in
- •5. 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
- •6. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months
- •7. Willing to consume ova-lacto vegetarian diet
- •8. Willing to comply to all requirements of this study protocol as well as instructed by
- •the study personnel
- •9. Female subjects within normal limits or clinically non-significant laboratory
- •evaluation results for FSH & LH
- •10. Generally healthy as documented by gynecological examination and breast
- •examination
- •11. Female subjects of childbearing potential A) Practicing an acceptable non-hormonal contraceptive method of birth
- •control after consulting with principal investigator; and/or B) Surgically sterile (bilateral tubal ligation)
排除标准
- •1. Evidence of allergy or known hypersensitivity to Vitamin C or other related drugs or
- •other related drugs.
- •2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver
- •disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing
- •gallbladder disease.
- •3. Any major illness in the last three months or any significant ongoing chronic medical
- •Any disease or condition which might compromise the haemopoeitic,
- •gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central
- •nervous system, diabetes, psychosis or any other body system.
- •4. History of alcohol addiction or abuse.
- •5. 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 24.00 hours prior to check-in and throughout the entire study
- •6. Consumption of grapefruit and its juice and poppy containing foods for at least 72.00
- •hours prior to check-in and throughout the study.
- •7. Subjects who taken any prescription medications, over the counter medicinal
- •products, herbal medications within 14 days prior to study check in and throughout
- •8. History of dehydration from diarrhea, vomiting or any other reason within a period of
- •24.00 hours prior to study check-in of each period.
- •9. An unusual or abnormal diet within 48.00 hours prior to study check-in of each
- •period, for whatever reason e.g. because of fasting due to religious reasons.
- •10. Subject who had participated in any other study within the 90 days of check-in.
- •11. History of difficulty in swallowing.
- •12. Positive results for drugs of abuse (Marijuana-THC, amphetamine-AMP,
- •barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in
- •urine prior to check-in of this study period.
- •13. Positive results for alcohol breath test prior to check-in of any study period
- •14. Any blood donation / excess blood loss within 90 days of check-in.
- •15. Systolic blood pressure less than 90mrn Hg or more than 140mmHg and diastolic
- •blood pressure less than 60 mmHg or more than 90 mmHg.
- •16. Ingestion of any hormonal agent at any time within 14 days prior to start of study
- •17. Female subjects demonstrating a positive pregnancy screen.
- •18. Female subjects whose menstruation cycle coincides with the study periods.
- •19. Female subjects who are currently lactating.
- •20. Females likely to become pregnant during conducting of the study
- •21. Use of hormone replacement therapy for a Period of 06 months prior to dosing.
- •22. Use of any oral contraceptives including estrogen and progestin combined pills and
- •progestin only pills within 28 days prior to period I dosing).
研究者
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