CTRI/2024/04/066483已完成2 期
A randomized, double blind, placebo controlled, three arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal CoQ-10 formulations in plasma in healthy volunteers - NI
SPECNOVA LLC0 个研究点目标入组 18 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
- 18
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)
- •2. Age should be between 18-45 years of age (both inclusive), weighing at
- •least 50 kg.
- •3. 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.
- •4. 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.
- •5. 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 CoQ 10 products or any food or other drugs.
- •2. Subjects who had taken drugs to reduce fat or statins or vitamin supplements (including vitamin E) during the last month.
- •3. Subject with resting hypotension (BP 140 /90) and pulse rate below 50/min and more than 100/min.
- •4. Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, 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.
- •5. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •6. Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
- •7. Subject who has a history of alcoholism, drug abuse or Smoking.
- •8. Subjects who are hypersensitive to Heparin
- •9. Subjects who participated in any other clinical study in the past three months.
- •10. Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X ray (PA View).
- •11. Subject who has difficulty with donating blood.
- •12. Subject with history of difficulty in swallowing.
- •13. Subject who has unsuitable veins for repeated venipuncture.
研究者
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