A randomized, double blind, three period, three arm, single center, single dose, crossover bioavailability study of turmeric extract formulations in 18 healthy human adult male subjects, under fasting condition.

Arjuna Natural Extracts Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: Other
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Ba/be

入排标准

入选标准

•1 Subject who are able and ready to provide written informed consent.
•2 Subjects must be healthy human male subjects within 18-40 years of age (both inclusive), weighing at least 50 kg.
•3 Subjects should be having Body Mass Index (BMI) in the range 18.5-30.0 kg/m2.
•4 Subjects must be of normal health as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 21 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.
•6 Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.

排除标准

•1 Subjects incapable of understanding the informed consent process or not ready to sign informed consent.
•2 Subjects with significant history of hypersensitivity to turmeric or turmeric extracts or curcuminiods or to any drugs.
•3 Subject with of presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of curcuminoidsto undesired effects. -
•4 Subjects with active peptic ulceration or a history of peptic ulceration.
•5 Subject with resting hypotension (BP <90 /60) or hypertension (BP > 139 /89).
•6 Subject with Pulse rate below 50/ min. and above 99/min.
•7 Subjects with or prior history of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
•8 Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
•9 Subjects with a history of known food allergy.
•10 Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
•11 Use of an investigational device or investigational drug within 90 days or 6 half-lives.
•12 Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs within the last 14 days prior to the study.
•13 Subject who have a History of alcoholism, drug abuse or Smoking.
•14 Subjects who participated in any other clinical study requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL includes the total blood loss that will occur during the study).
•15 Subject with clinically significant abnormal lab values / abnormal ECG / abnormal Chest X-ray (PA View).
•16 Subject who has difficulty with donating blood.

研究者

发起方

Arjuna Natural Extracts Ltd

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