| CTRI Number |
CTRI/2019/12/022361 [Registered on: 13/12/2019] Trial Registered Prospectively |
| Last Modified On: |
30/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Multiple oral dose pharmacokinetics of vitamin K2-7 capsules 350 mcg under fed condition |
|
Scientific Title of Study
|
An open label, parallel study to evaluate the steady state pharmacokinetics of Vitamin K2-7 capsules 350 mcg of Synergia Life Sciences Pvt. Ltd after multiple dose administered in normal, healthy, adult, human male subjects under fed condition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 0381-19 Version: 1.0 dated 24 Oct 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alpesh Parmar |
| Designation |
Principal Investigator |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Clinical Department.
Lambda house, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
91-79-40202020 |
| Fax |
91-79-40202021 |
| Email |
alpeshjparmar@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpesh Parmar |
| Designation |
Principal Investigator |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Clinical Department.
Lambda house, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
91-79-40202020 |
| Fax |
91-79-40202021 |
| Email |
alpeshjparmar@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Jadhav |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt Ltd |
| Address |
1503, Universal Majestic,
P L Lokhande Marg,
Ghatkopar Mankhurd Link Road,
Govandi.
Mumbai
MAHARASHTRA
400043
India |
| Phone |
91-22-62669600 |
| Fax |
|
| Email |
shashank@viridisbiopharma.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd |
| Address |
1503, Universal Majestic,
P L Lokhande Marg,
Ghatkopar Mankhurd Link Road,
Govandi. Mumbai 400 043. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alpesh Parmar |
Lambda Therapeutic Research Ltd |
Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota, Ahmedabad - 382481, Gujarat, India.
Ahmadabad
GUJARAT |
91-79-40202020
91-79-40202021
alpeshjparmar@lambda-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Conscience Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Vitamin K2-7 |
Vitamin K2-7 capsule of 350 mcg to be consumed once daily immediately after dinner for 21 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize the Steady state pharmacokinetic profile of Vitamin K2-7 capsule 350 mcg after multiple oral dose administration in normal, healthy, adult, human male subjects under fed condition. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the subjects |
22 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/12/2019 |
| Date of Study Completion (India) |
18/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open label, parallel study to evaluate the steady state pharmacokinetics study in normal, healthy, adult, human male subjects under fed condition. No. of subjects: 15 Vitamin K2-7 capsule of 350 mcg to be consumed everyday immediately after dinner for 21 days. Vitamin K2-7 along with Uncarboxylated Osteocalcin (ucOC) and Carboxylated Osteocalcin (cOC) will be measured at baseline, 3rd, 7th, 14th and 21st day. |