A study to determine comparative bioavailability of NCT023 extracts Vs Curcuma longa extract with Piperine in healthy volunteers. - NI

isarga Biotech Pvt. Ltd.0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1. Healthy male and female subjects
•2. Ability to communicate adequately with the investigator
•3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.

•1. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal,
•hematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or
•psychiatric disease, any type of porphyria.
•2. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or
•except herniotomy.
•3. Subjects who have participated to any drug research within the last one month before the first
•drug administration.
•4. Subjects suspected to have a high probability of non-compliance to the study procedure and/or
•completion of the study according to the investigator’s judgement.
•5. History of allergic response to Curcuma longa.
•6. Subjects who have any chronic disease which might interfere with absorption, distribution,
•metabolism or excretion of the drug.
•7. History of drug and alcohol abuse.
•8. History of difficulty in swallowing.
•9. Pregnant and Lactating females
•10. Subjects having any medical or surgical condition that would require immediate medical or
•surgical intervention at the time of screening
•11. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
•12. Other conditions, which in the opinion of the investigators makes the patient unsuitable for
•enrolment or could interfere in adherence to of the study protocol

发起方

isarga Biotech Pvt. Ltd.