A Study to see Levels of Vitamin MK-7 in blood and Stool Samples and microorganisms present in Stool Samples of Healthy Subjects

Not Applicable

• Registration Number: CTRI/2022/12/048578
• Lead Sponsor: Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified