| CTRI Number |
CTRI/2025/10/096435 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
bioavailability study of vitamin K in healthy adult human subjects. |
|
Scientific Title of Study
|
An open-label, balanced, randomized, single-dose, four treatment, single period, parallel oral bioavailability study comparing the test product of BioMK7 CWD 1 mg capsule and BioMK7 CWS 1 mg capsule by Morel Bio Science Private Limited with that of reference product of Vita MK7 1 mg capsule by Gnosis lesaffre and Menaquine Gold 1 mg capsule by Viridis Biopharma in healthy, adult human participants under fasting conditions. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NT-NU-001-25, Version 01, 04 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C Amulya |
| Designation |
Principal investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad, Telangana
Hyderabad
TELANGANA
500018
India |
| Phone |
8801549488 |
| Fax |
|
| Email |
amulya.c@noahtherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Amulya |
| Designation |
Principal investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad, Telangana
Hyderabad
TELANGANA
500018
India |
| Phone |
8801549488 |
| Fax |
|
| Email |
amulya.c@noahtherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Amulya |
| Designation |
Principal investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad, Telangana
Hyderabad
TELANGANA
500018
India |
| Phone |
8801549488 |
| Fax |
|
| Email |
amulya.c@noahtherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Morel Bio Science Private Limited, No.17/18, Bangalore International
Public School Road, Chikkallasandra, Uttarahalli Main Road, Bangalore
Karnataka- 560061. Email: sunil@kih.in Phone: 096866 88859 |
|
|
Primary Sponsor
|
| Name |
Morel Bio Science Private Limited |
| Address |
No.17/18, Bangalore International Public School Road, Chikkallasandra, Uttarahalli Main Road, Bangalore, Karnataka- 560061.Email: sunil@kih.in Phone: 096866 88859 |
| Type of Sponsor |
Other [Nutraceutical and Biopharmaceutical company] |
|
|
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 P Venkatesh |
Noah Therapeutics Private Limited |
Noah Therapeutics Private Limited, D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA |
9440383778
venkat@noahtherapeutics.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos 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 |
| Intervention |
BioMK7 CWD 1 mg capsule |
Manufactured by: Morel Bio Science Private Limited
Dose: Single dose of 1mg capsule
Total duration of the study: At least 11 days to complete the clinical phase of the study.
|
| Intervention |
BioMK7 CWS 1 mg capsule |
Manufactured by: Morel Bio Science Private Limited
Dose: Single dose of 1 mg capsule
Total duration of the study: At least 11 days to complete the clinical phase of the study. |
| Comparator Agent |
Menquine Gold 1 mg capsule |
Manufactured by: Viridis Biopharma
Dose: Single dose of 1 mg capsule
Total duration of the study: At least 11 days to complete the clinical phase of the study. |
| Comparator Agent |
Vita MK7 1 mg capsule |
Manufactured by: Gnosis lesaffre
Dose: single dose of 1 mg capsule
Total duration of the study: At least 11 days to complete the clinical phase of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, non-smoking, non-alcoholic, adult, human volunteer (Male and/or non-pregnant, non-lactating female) aged between 18 to 45 years (inclusive of both).
2. Volunteer with a BMI between 18.5 kg/m2 and 30.0 kg/m2 (inclusive of both) and weight at least 50 kgs for male subjects and 45 kgs for female volunteers.
3. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the dosing.
4. Participant having normal 12-lead electrocardiogram (ECG).
5. Participant having normal chest X- Ray (P/A view).
6. A negative urine screen result for drugs of abuse.
7. A negative urine alcohol or breath alcohol test result.
8. Participant able to communicate effectively.
9. Participant willing to adhere to protocol requirements as evidenced by written informed
consent approved by an IEC/IRB.
10. Participants willing to give written informed consent and adhere to all the requirements of this protocol.
11. Ability to fast for at least 10.00 hours prior to dosing, 04.00 hours post-dose.
12. A negative pregnancy test result for female volunteers.
13. Male participant agreeing to use appropriate contraceptive measures like double barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam) and should not donate sperm during the study and for 07 days following last dose of the study medication.
14. If study participant is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence:
Or
Is postmenopausal for at least 1 year.
Or
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to Menaquinone-7 (MK-7), or any of the excipients in the formulation.
2. History or presence of any medical condition or disease according to the opinion of the physician.
3. Volunteers with metabolic or gastrointestinal diseases, chronic degenerative or inflammatory diseases, anaemia, pregnancy, diabetes mellitus, soy allergy, abuse of drugs/alcohol, use of corticosteroids, oral anticoagulants, salicylates, antibiotics, use of vitamin K supplements and high dietary intake of vitamin K.
4. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
5. Difficulty with donating blood or difficulty in accessibility of veins.
6. Difficulty in swallowing capsules.
7. An unusual or abnormal diet within 48.00 hours prior to study check-in, for whatever reason e.g., because of fasting due to religious reasons.
8. Participants who had planned surgery during the course of the trial.
9. History or current diagnosis of any cancer.
10. History or presence of significant alcoholism or drug abuse.
11. History of smoking.
12. History of gall bladder issues.
13. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg.
14. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
15. Pulse rate less than 60 beats/minute or more than 100 beats/minute.
16. Respiratory rate less than 14 breaths per minute or more than 18 breaths per minute.
17. Any significant/abnormal values of laboratory tests.
18. Major illness during 90 days before screening.
19. Use of any prescribed medication or OTC medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study.
20. Use of any medications or dietary supplements of Vitamin K during last two weeks.
21. Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and unwilling to follow throughout the study.
22. Participation in a drug research study within past 90 days.
23. Donation of blood in the past 90 days prior to study check-in.
24. In case of female volunteers, Pregnant or lactating Women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the oral bioavailability in healthy adult human subjects under fasting conditions. |
Baseline Pre-dose blood samples will be collected at Day-2 and Day -1, Day 1 and the post-dose samples will be collected on Days 1,2,3,4,5,6 and 8 at 01.00, 02.00, 03.00, 04.00, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00, 120.00 and 168.00 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of the test product in healthy, adult, human participants. |
Vital signs and well-being will be evaluated at the time of screening, check-in and at -48.00, -24.00, 00.00 before dosing and 02.00, 04.00, 06.00, 09.00, 24.00, 36.00, 48.00, and 60.00 hours after dosing and at the time of check-out. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Nutraceutical study. The title of study is An open-label, balanced, randomized, single-dose, four treatment, single period, parallel, oral bioavailability study comparing the test products BioMK7 CWD 1 mg capsule and BioMK7 CWS 1 mg capsule by Morel Bio Science Private Limited with that of reference products Vita MK7 1 mg capsule by Gnosis lesaffre and Menquine Gold 1 mg capsule by Viridis Biopharma in healthy, adult human participants under fasting conditions. The primary objective of the study is to demonstrate oral bioavailability of the investigational products and the secondary objective of the study is To monitor the safety and tolerability of the test product in healthy, adult, human participants. A total of 44 healthy, adult, human participants shall be enrolled in the study. The total duration of the study will be at least 11 days. A total of 29 pre-dose and post-dose blood samples will be collected in single period for the study to meet primary objective. |