A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation Phase 1 Clinical Study to Evaluate the Safety & Tolerability of HDCD-092330 in Healthy Volunteers - NI

Himalaya Wellness Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1.Healthy adult male or female subjects aged between 18- 45 years.
•2.Healthy subjects as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests (as specified in Appendix1).
•3.Subjects who refrain from taking any oral/ topical medication at least 15 days prior and during the study period. (Paracetamol to be allowed within 15 days prior to study, non-regular SOS medications to be allowed during the study)
•4.Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
•5.Subjects willing to sign informed consent and follow the study procedure

•1.Subjects with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital or any other disorder that can interfere with the study conduct and outcome in the opinion of the Investigator. (Subject with any chronic medical condition under control to be also excluded).
•2.Subjects with known history of GIT disorders like GERD, Gastritis or any other discomfort (as assessed by GSRS score (Appendix 2) more than 1 for any one of the 15 questions to be excluded)
•3.Subjects with history of significant renal disease or urinary symptoms; past history of urinary stones, or history of any previous urogenital invasive procedures.
•4.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product.
•5.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications.
•6.Pregnant and lactating women (as assessed by UPT & History of Amenorrhea).
•7.Male subjects who refrain to use adequate contraception and not donate sperm from first admission to the study until 90 days after the follow-up visit.
•8.Known alcohol or any other substance abuse according to DSM-V criteria.
•9.Any other reason (physical, psychological or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.

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