CTRI/2022/12/048410进行中（未招募）不适用
A Prospective study to assess serum levels of Vitamin MK-7 in Healthy Subjects
Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company9 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年12月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- To assess the serum levels of Vitamin MK-7 in healthy subjects.
研究概览
简要总结
This study is a Prospective study to assess serum levels of Vitamin MK-7 in Healthy Subjects
The primary objective of the study is to assess the serum levels of Vitamin MK-7 in healthy subjects and secondary objective of the study is to assess the gene expression level of MK-7 related markers in serum.
Primary Endpoint is to assess the serum levels of Vitamin MK-7 in healthy subjects
Secondary Endpoint is to assess the gene expression of MK-7 related markers in serum.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Male or Female subjects between 18 to 65 years of age (Both Inclusive).
- •Subjects with Normal physical examination at screening visit,
- •Subjects with Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest at screening
- •Subjects with Laboratory results within normal range or clinically non-significant (CBC, total bilirubin, SGOT, SGPT ,S.Creatinine and urinalysis),
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subjects with any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major diagnosed disease or malignancy.
- •Presence or history of any gastrointestinal surgery except appendectomy or except herniotomy.
- •Subjects Having the Body Mass Index ranged between 18.5-24.9 kg/m
- •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.
- •Subjects using of vitamin K-containing multivitamins or vitamin K supplements within 21 days prior to screening.
- •Subjects who are on antibiotics or had antibiotic treatment 4 weeks prior to screening visit
- •History of drug and alcohol abuse.
- •Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.
- •Female subjects who are pregnant or lactating.
结局指标
主要结局
To assess the serum levels of Vitamin MK-7 in healthy subjects.
时间窗: Day 1
次要结局
- To assess the gene expression of MK-7 related markers in serum.(Day 1)
研究者
研究点 (9)
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