| CTRI Number |
CTRI/2024/12/078004 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An open label, randomized, balanced, two treatment, one sequence, single period, parallel, single-dose oral bioequivalence study of Liposomal Glutathione powder sachet 2.5 gm with Plain Glutathione 2.5 gm powder sachet |
|
Scientific Title of Study
|
An open label, randomized, balanced, two treatment, one sequence, single period, parallel, single-dose oral bioequivalence study of Liposomal Glutathione powder sachet 2.5 gm (contains 01 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India with Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India in normal healthy, adult human subjects under fasting condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya A MD |
| Designation |
Principal Investigator |
| Affiliation |
M/s Notrox Research Pvt Ltd (NRPL) |
| Address |
Ms Notrox Research Pvt Ltd NRPL No 19 2nd Floor Bikasipura road JC Industrial layout off Kanakapura Road Behind Metro Cash and carry
Bangalore
No 19/3, 3rd Floor, Bikasipura Main Rd, JC Industrial Layout
Bangalore
KARNATAKA
560062
India |
| Phone |
7760829333 |
| Fax |
|
| Email |
drdivya-a@notroxresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya A MD |
| Designation |
Principal Investigator |
| Affiliation |
M/s Notrox Research Pvt Ltd (NRPL) |
| Address |
Ms Notrox Research Pvt Ltd NRPL No 19 2nd Floor Bikasipura road JC Industrial layout off Kanakapura Road Behind Metro Cash and carry
Bangalore
No 19/3, 3rd Floor, Bikasipura Main Rd, JC Industrial Layout
Bangalore
KARNATAKA
560062
India |
| Phone |
7760829333 |
| Fax |
|
| Email |
drdivya-a@notroxresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya A MD |
| Designation |
Principal Investigator |
| Affiliation |
M/s Notrox Research Pvt Ltd (NRPL) |
| Address |
Ms Notrox Research Pvt Ltd NRPL No 19 2nd Floor Bikasipura road JC Industrial layout off Kanakapura Road Behind Metro Cash and carry
Bangalore
No 19/3, 3rd Floor, Bikasipura Main Rd, JC Industrial Layout
Bangalore
KARNATAKA
560062
India |
| Phone |
7760829333 |
| Fax |
|
| Email |
drdivya-a@notroxresearch.com |
|
|
Source of Monetary or Material Support
|
| #191-A, Corner Plot, 1st Stage, KIADB Ind. Area, Vasanthanarasapura, Tumkur-572128. |
|
|
Primary Sponsor
|
| Name |
Samarth Biorigins LLP |
| Address |
191 A Corner Plot 1st Stage KIADB Ind Area,Vasanthanarasapura Tumkur572128 |
| 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 A Divya |
Notrox Research Pvt Ltd |
No 19 3 2nd Floor Bikasipura road JC Industrial layout off Kanakapura Road Behind Metro Cash and carry
Bangalore
KARNATAKA |
7760829333
drdivya-a@notroxresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDSTARSPECIALITYHOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers as subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Liposomal Glutathione 2.5 gm powder sachet (contains 01
gm of L-Glutathione) (LipoDuoâ„¢ Glutathione). |
After an overnight fasting of at least 10.00 hours, a single dose of Liposomal Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (LipoDuo™ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India or Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India, is dispersed in 20 mL of water and administered orally along with 240±2 mL of water to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive either one treatment of Test product or Reference product.
Total duration of study is 3 days |
| Comparator Agent |
Plain Glutathione 2.5 gm powder sachet (contains 01 gm of
L-Glutathione). |
After an overnight fasting of at least 10.00 hours, a single dose of Liposomal Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (LipoDuo™ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India or Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India, is dispersed in 20 mL of water and administered orally along with 240±2 mL of water to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive either one treatment of Test product or Reference product.
Total duration of study is 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy, adult human, subjects aged between 18-45 years (both inclusive)
weighing at least 50 kg at the time of screening.
ï‚· Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both
inclusive) at the time of screening.
ï‚· Normal or clinically insignificant findings during screening, medical history,
medical examination, laboratory evaluations, 12 lead ECG and X-ray chest
(posterior-anterior view) recordings.
ï‚· Able to comply with the study procedures, in the opinion of the Principal
Investigator.
ï‚· Compliance with study specific restrictions and prohibitions.
ï‚· Able to give voluntary written informed consent for participation in the trial.
In case of Female subjects:
ï‚· The Healthy adult female 18-45 years (both inclusive) of ages, perimenopause
and post-menopausal female subjects shall be included in this study.
ï‚· Female subjects who are of child bearing potential and are willing to use a
suitable and effective double barrier contraceptive method or non-hormonal
intra uterine device during the study.
ï‚· Female subjects who are tested negative for serum pregnancy test at the time
of check-in.
ï‚· Female subjects who are tested negative for urine pregnancy test at the time
of screening. |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity or idiosyncratic reaction to the study drug or any
related drug.
ï‚· History or presence of any disease or disorder known to influence bone
metabolism, compromise the hemopoietin, renal, hepatic, endocrine,
pulmonary, central nervous, cardiovascular, immunological, dermatological,
gastrointestinal, musculoskeletal or any other body system.
Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the
time of screening.
ï‚· Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the
time of screening.
ï‚· Pulse rate below 60 beats/minute or above 100 beats/minute at the time of
screening.
ï‚· Respiratory rate below 12 or above 20 breaths per minute at the time of
screening.
ï‚· Body temperature below 96.2oF or above 99.8oF at the time of screening.
ï‚· SpO2 less than 94% at the time of screening.
ï‚· Ingestion of any medicine at any time within 14 days prior to IP administration
in period I. In any such case subject selection will be at the discretion of the
Principal Investigator.
ï‚· Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
ï‚· Smokers and Alcoholics.
ï‚· History of dehydration from diarrhea, vomiting or any other reason within a
period of 24.00 hours prior to study check-in.
ï‚· An unusual or abnormal diet within 48.00 hours prior to study check-in,
whatever reason e.g. because of fasting due to religious reasons.
ï‚· The presence of clinically significant abnormal laboratory values during
screening.
ï‚· Use of any recreational drugs or history of drug addiction or testing positive
in pre-study urine drug screening and Urine alcohol test.
ï‚· A history of difficulty with donating blood or having donated blood in the
preceding 90 days for males / 120 days for females prior to the start of the
study.
ï‚· Subject who has participated in any other clinical study involving drug
administration and collection of blood samples in the 90 days for males / 120
days for females preceding the start of the study.
ï‚· Difficulty in swallowing dispersed solution.
ï‚· Positive HIV, VDRL/RPR, Hepatitis B and C tests.
ï‚· Subjects who have used any drugs or substances known to be strong inhibitors
or inducers of Cytochrome P450 enzymes within 14 days prior to IP
administration in period I.
ï‚· Female volunteers who are of child bearing potential but not sterilized or not
willing to use contraceptives.
ï‚· Female Subjects with depot injections or implants within past 6 months.
ï‚· History of undiagnosed vaginal bleeding (for females only).
ï‚· Female subjects who demonstrates a positive pregnancy during screening or
currently breast-feeding.
Female volunteer who has used implanted or injected hormonal contraceptives
anytime during the 6 months prior to study or used hormonal contraceptives
within 14 days before dosing.
ï‚· Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmax, AUC0-t & AUC0-inf |
-12.00, - 02.00, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00 and 24.00 Edit || Delete
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tmax, Kel, t½, AUCExtrapolated%, CL and Vz |
-12.00, - 02.00, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00 and 24.00 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
25/12/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
An open label, randomized, balanced, two treatment, one sequence, single period, parallel, single-dose oral bioequivalence study of Liposomal Glutathione powder sachet 2.5 gm (contains 01 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India with Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India. To compare and assess the rate and extent of absorption of Liposomal Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India with Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India under fasting conditions. To monitor the adverse events and to ensure the safety of the subjects following swallow of a single dose of test product of Liposomal Glutathione 2.5 gm powder sachet (contains 1 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) and reference product of Plain Glutathione 2.5 gm powder sachet (contains 1 gm of L-Glutathione) to adult human subjects under fasting condition under fasting conditions. |