CTRI/2024/04/066274尚未招募1 期
An Open-Label, Single Arm Clinical Study to Evaluate the Safety of HGLG-032406 (IN-100001206) in Healthy Adult Females. - Nil
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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.Healthy adult females within age group of 18 to 40 years.
- •2.Healthy females as determined by the investigator based on a medical evaluation including medical history, physical examinations, and laboratory examinations.
- •3.Subjects willing to sign an informed consent document.
- •4.Subjects willing to adhere to protocol requirements throughout the study period.
- •5.Subjects who have not participated in any clinical study in the past 30 days
排除标准
- •1.Subjects with known clinically significant serious cardiovascular, neurological, respiratory, gastrointestinal, genitourinary, congenital or any other disorder as determined by the investigator.
- •2.Women who are pregnant, nursing, or planning a pregnancy during study entry and throughout the duration of the study.
- •3.Subjects with lactose intolerance (as the IP is to be taken with milk).
- •4.Subjects with known allergies to any of the ingredients of the investigational product.
- •5.Subjects with clinically significant pre-existing systemic disease necessitating long-term medications as determined by the investigator.
- •6.Subjects not willing to refrain from using adequate contraception and hormonal medications one month prior and during the study.
- •7.Subjects not willing to refrain from taking any other similar supplements during the study period.
- •8.Subjects not willing to abstain from excessive intake of recreational products like tobacco/pan chewing, smoking, alcohol and any other as determined by the investigator during the study period.
研究者
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