Multiple oral dose pharmacokinetics of vitamin K2-7 capsules 350 mcg under fed conditio

Phase 2

Completed

• Registration Number: CTRI/2019/12/022361
• Lead Sponsor: Synergia Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-18
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

1. Non-smokers, normal, healthy, adult, human male volunteers between 18 to 45 years of age (both inclusive).

2. Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg / height in sq.m.

3. Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.

4. Able to understand and comply with the study procedures, in the opinion of the investigator.

5. Able to give voluntary written informed consent for participation in the study.

Exclusion Criteria

1. Known hypersensitivity to Vitamin K2-7 or any excipients or any related drug or any substance.

2.History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

3. Ingestion of a medication (prescribed & over the counter (OTC) medication including herbal remedies) at any time within 14 days prior to first dosing. In any such case subject selection will be at the discretion of the Principal Investigator / designee.

4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.

5. A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hours prior to check-in.

6. Smokers or who have smoked within last 06 months prior to start of the study.

7. Consumption of natto or any fermented food products such as Dosa, Ideli, Curd, Yogurt and other vitamin K containing products within 72 hours prior to check in.

8. The presence of clinically significant abnormal laboratory values during screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified