| CTRI Number |
CTRI/2021/02/031421 [Registered on: 19/02/2021] Trial Registered Prospectively |
| Last Modified On: |
29/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
TO DETERMINE THE PHARMACOKINETICS |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg |
|
Scientific Title of Study
|
A Double-Blind, Balanced, Randomized, Single dose, Parallel arm, Placebo controlled study to determine the Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg Manufactured by Inventia Healthcare Ltd in Healthy, Adult, Human Subjects Under Fasting Conditions. |
| Trial Acronym |
SLS-CT-0006-20-VITA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Rsenthurselvi |
| Designation |
Prinicipal Investigator |
| Affiliation |
SpinosLifescience Research Pvt Ltd |
| Address |
SpinoS Life Science and Research Pvt Ltd No29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu India
No29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
0422-2642491 |
| Fax |
0422-2642492 |
| Email |
senthurselvi.r@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rsenthurselvi |
| Designation |
Prinicipal Investigator |
| Affiliation |
SpinosLifescience Research Pvt Ltd |
| Address |
SpinoS Life Science and Research Pvt Ltd No29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu India
No29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu India
TAMIL NADU
641029
India |
| Phone |
0422-2642491 |
| Fax |
0422-2642492 |
| Email |
senthurselvi.r@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
RAbiraamasundari |
| Designation |
Managing Director |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Spinos LifeScience and Research Private No29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu India
No29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
0422-2642491 |
| Fax |
0422-2642492 |
| Email |
abirami@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Limited |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Limited |
| Address |
Unit 703 -704 7th Floor, Hubtown Solaris N.S. Phadke Marg, Andheri (East)
Mumbai 400069,
Maharashtra India
|
| 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 |
| DrRSenthurSelvi |
Spinos Life Science and Research Private Limited |
No 29 A Krishna Madhuravanam Vellakinarpirivu Thudiyalur Coimbatore No 29 A Krishna Madhuravanam Vellakinarpirivu Thudiyalur Coimbatore
Coimbatore
Coimbatore
TAMIL NADU |
0422-2642491
0422-2642492
senthurselvi.r@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Under Fasting Conditions. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Tablets |
Manufactured by Inventia Healthcare Limited, India.
In study period, after an overnight fasting of at least 10.00 hours, in morning Single dose of Placebo will be administered (according to the randomization schedule) with 240 ml of water at ambient temperature, to the subjects, in sitting upright posture, under the supervision of Investigator or Medical Officer and trained study personnel including the Quality Assurance auditor(s).
Test and Placebo should not be chewed or crushed and should be swallowed whole.
This activity will be followed by mouth check with the help of torch light and tongue depressor to assess compliance of dosing.
Note: Dosing will be done under yellow monochromatic light.
|
| Intervention |
Vitamin C Sustained Release Tablets 500 mg |
Manufactured by Inventia Healthcare Limited, India.
In study period, after an overnight fasting of at least 10.00 hours, in morning Single dose of Test Product (T) will be administered (according to the randomization schedule) with 240 ml of water at ambient temperature, to the subjects, in sitting upright posture, under the supervision of Investigator or Medical Officer and trained study personnel including the Quality Assurance auditor(s).
Test and Placebo should not be chewed or crushed and should be swallowed whole.
This activity will be followed by mouth check with the help of torch light and tongue depressor to assess compliance of dosing.
Note: Dosing will be done under yellow monochromatic light.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers meeting all of the following criteria will be considered for enrollment in the study:
• Subjects who agree to abstain from all vitamin C rich food / fruits etc. at least 15 days before the study.
• Normal, healthy, adult, human subjects of age between 18to 45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2 (according to the formula of BMI is equal to weight (kg) / [height (m)]2).
• Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.
• Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
• Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
• Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
• Non-smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
• Willing to comply to all requirements of this study protocol as well as instructed by the study personnel.
• Generally healthy as documented by gynecological examination and breast examination (for female subjects).
• Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.
• Female subjects of childbearing potential;
• Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam and/or
• Surgically sterile (bilateral tubal ligation).
|
|
| ExclusionCriteria |
| Details |
Volunteers with history or significant presence of the following will be excluded from participation/enrollment in the study:
• Evidence of allergy or known hypersensitivity to Vitamin C or its inactive ingredients.
• Subjects having plasma levels of vitamin C ≤ 11 µmol/L during screening
• Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus and pre-existing gallbladder disease.
• Any major illness in the last three months or any significant ongoing chronic medical illness.
• Renal or liver impairment.
• Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, or any other body system.
• History or presence of alcohol addiction or abuse.
• Consumption of caffeine and /or xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study.
• Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study.
• Subjects who have taken any prescription medications or any vitamin C supplements within 14 days prior to study check-in and throughout the study and any over the counter medicinal products, herbal medications within 15 days prior to study check-in and throughout the study.
• Subjects who have taken an unusual diet, for whatever reason (e.g. low salt or vitamin C ) for 48.00 hours prior to dosing and throughout the study.
• Subject who had participated in any other study within the 90 days of check-in.
• History of difficulty in swallowing.
• History of difficulty in accessibility of veins.
• Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of this study period.
• Positive results for alcohol test(by breathalyzer/urine samples) prior to check-in of study period.
• Any blood donation / excess blood loss within 90 days of check-in.
• Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
• Use of hormone replacement therapy for a Period of 06 months prior to dosing.
• Female subjects demonstrating a positive pregnancy screen.
• Female subjects who are currently lactating.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Pharmacokinetics of Vitamin C Sustained Release Tablets 500 mg Manufactured by Inventia Healthcare Ltd in healthy, adult human subjects under fasting conditions. |
00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a single dose administered in Healthy, Adult, Human Subjects under Fasting conditions. |
00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 04.00, 05.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2021 |
| Date of Study Completion (India) |
19/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="12" |
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)?
Response - NO
|
|
Brief Summary
|
Ascorbic acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a slight acidic taste. It is an anti-scorbutic product.This study is being conduct to determine the Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg Manufactured by Inventia Healthcare Ltd in Healthy, Adult, Human Subjects Under Fasting Conditions.To evaluate the Pharmacokinetics of Vitamin C Sustained Release Tablets 500 mg Manufactured by Inventia Healthcare Ltd in healthy, adult human subjects under fasting conditions.
Pharmacokinetic & Statistical Parameters Employing the estimated concentration vs. time profiles of Vitamin C (Only Ascorbic acid) using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA, the following pharmacokinetic parameters will be calculated: Primary parameters are Cmax, AUC0-t & AUC0-¥. Secondary parameters are tmax, Kel, t½. Statistical analysis for Vitamin C (Only Ascorbic acid)will be done using SAS® software Version 9.4 or higher version of SAS Institute Inc., USA. |