| CTRI Number |
CTRI/2025/02/080160 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral Bioavailability Study of Glyteine 400 mg Capsules |
|
Scientific Title of Study
|
A Single-treatment, Single-period Clinical Study to Investigate the Effect of a Single Dose of Glyteine
400 mg Capsules on Time-Dependent Changes of Glutathione Levels in Blood Fractions in healthy
human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 007-24, version 01 & 31 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Tejo Swaroop Kumar |
| Designation |
Principal Investigator |
| Affiliation |
Noah Therapeutics Private Limited |
| Address |
Noah Therapeutics Private Limited
D.No.7-1-645/A, Sanathnagar, Erragadda,
TELANGANA
500018
India |
| Phone |
09958509329 |
| Fax |
|
| Email |
tejoswaroopd@noahtherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Biospecialties International Pty. Ltd., 4-8 Ferndell Street South, Granville, New South Wales, 2142 Australia |
|
|
Primary Sponsor
|
| Name |
Biospecialties International Pty Ltd |
| Address |
Biospecialties International Pty. Ltd., 4-8 Ferndell Street South, Granville, New South Wales, 2142 Australia. |
| Type of Sponsor |
Other [Australian Private 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 D Tejo Swaroop Kumar |
Noah Therapeutics Private Limited |
D.No.7-1-645/A, Sanathnagar, Erragadda,
Hyderabad, Telangana -500018 (India)
Hyderabad
TELANGANA |
09958509329
tejoswaroopd@noahtherapeutics.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vasavi Medical and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glyteine 400 mg capsules |
Single dose of single unit of Glyteine 400 mg capsules will be administered orally.
Total duration of the study intervention is 02 days from check-in to end of the study. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy human subjects (Male and/or Peri to Post menopausal Women) aged between 50 to 70 years (inclusive of both).
2. Volunteers with a BMI between 18.5-30.0 kg/m2 (inclusive of both) and body mass not less than 50.00 kg for male and 45.00 kg for females.
3. Volunteers willing to give written informed consent and adhere to all the requirements of this protocol.
4. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the dosing. |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to Glyteine or Glutathione or any component of this medication.
2. Incapable of understanding the informed consent information.
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological,dermatological, neurological or psychiatric disease or disorder.
4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
5.History of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), diabetic
pre-coma.
6. History or presence of alcoholism or drug abuse.
7. History or presence of Sulphur intolerance.
8. History or presence of asthma, urticaria or other allergic reactions.
9. History or presence of gastric and/or duodenal ulceration.
10. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
11. History or presence of cancer.
12. Difficulty with donating blood.
13. Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study.
14. History or presence of smoking.
15. Volunteers consumed tobacco/tobacco containing products, pan or pan masala, gutkha, masala (containing betel nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.
16. Volunteers consumed caffeine and/or xanthine- containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study
17. Major illness during the 90 days before screening.
18. Participation in a drug research study within 90 days of screening.
19. Donation of blood within 90 days of screening.
20. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
21. History or presence of easy bruising or bleeding.
22. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
23. Pregnant woman and nursing mothers.
24. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing.
25. Woman of child bearing age who do not agree to follow a reliable method of contraception during study period.
26. Difficulty in swallowing solids like capsules, tablets. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the time-dependent changes in glutathione concentrations in blood fractions following the oral administration of Glyteine 400 mg capsules. |
The pre-dose blood samples (04 mL each) will be collected at -12.00,-2.00, and 0.00 hours (basal/homeostasis levels) prior to Glyteine administration. Post-dose blood samples (04 mL each) will be collected at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 7.00 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety & tolerability of orally administered Glyteine 400
mg capsules. |
Vital signs will be measured at the time of screening & Vital signs (body temperature, pulse rate & blood pressure) & questioning for well-being shall be before check-in, 01.00, 03.00 & 05.00 hours after dosing & before check-out of the stduy.
Laboratory evaluation shall be done at the time of screening & at end of the study. |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 single-treatment, single-period clinical study to investigate the effect of a single dose of Glyteine 400 mg capsules on time-dependent changes of Glutathione levels in blood fractions in healthy
human subjects. A total of 12 subjects aged between 50 to 70 years shall be recruited to evaluate the time-dependent changes in glutathione
concentrations in blood fractions, safety & tolerability of orally administered Glyteine 400
mg capsules. Total duration of the study shall be 2 days. Healthy human subjects who are eligible based on inclusion and exclusion criteria shall be recruited in the study. |