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临床试验/CTRI/2024/04/066274
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

Himalaya Wellness Company0 个研究点目标入组 0 人开始时间: 待定最近更新:

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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