CTRI/2024/04/066202已完成2 期
A Randomized, Open label, two arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal Vitamin-C formulations in healthy volunteers. - NI
Botanic Healthcare Pvt Ltd0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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.Subjects must be healthy human male and female (non-pregnant) subjects.
- •2.Age should be between 18-45 years of age (both inclusive)
- •3.BMI between 18.5 to 24
- •4.Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
- •5.Subjects with no evidence of underlying disease during the pre-study screening. They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 7 days prior to the commencement of the study.
- •6.Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
排除标准
- •1.Subjects who are allergic to vitamin C products or any food or other drugs.
- •2.Subject with resting hypotension (BP less than90 /60) or hypertension (BP greterthan140 /90) and pulse rate below 50 min and more than 100/min.
- •3.Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
- •4.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial haemorrhage.
- •5.Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs or many vitamin supplements within the last 14 days prior to the study.
- •6.Subject who has a history of alcoholism, drug abuse or Smoking.
- •7.Subjects who are hypersensitive to Heparin
- •8.Subjects who participated in any other clinical study in the past three months.
- •9.Subject with clinically significant abnormal lab values/ abnormal ECG abnormal Chest X ray (PA View).
- •10.Subject who has difficulty with donating blood.
- •11.Subject with history of difficulty in swallowing.
研究者
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