None listed
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the levels of Vitamin MK-7 in serum as well as in stools in healthy subjectsTimepoint: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the gene expression of MK-7 related markers in serumTimepoint: Day 1;To assess the Metagenomic Sequencing of the stool samplesTimepoint: Day 1 | — |
Countries
India
Contacts
Public ContactDr Shashank S Jadhav
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed