A Prospective Study to Assess Levels of Vitamin MK-7 in Serum and Stool Samples and Perform Metagenomic Sequencing of the Stool Samples in Healthy Subjects

Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•1. Healthy Male or Female subjects between 18 to 65 years of age (Both Inclusive).
•2. Subjects with Negative alcohol breath test results at screening
•3. Subjects with Normal physical examination at screening visit,
•4. Subjects with Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest at screening
•5. Subjects with Laboratory results within normal range or clinically non-significant (CBC, total bilirubin, SGOT, SGPT ,S.Creatinine and urinalysis),
•6. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

•1. 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.
•2. Presence or history of any gastrointestinal surgery except appendectomy or except herniotomy.
•3. Subjects Having the Body Mass Index ranged between
•18.5-24.9 kg/m2.
•4. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigatorâ??s judgement.
•5. Subjects using of vitamin K-containing multivitamins or vitamin K supplements within 21 days prior to screening. 6. Subjects who are on antibiotics or had antibiotic treatment 4 weeks prior to screening visit
•7. History of drug and alcohol abuse.
•8. Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.
•9. Female subjects who are pregnant or lactating.

发起方

Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company