PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 04:49:08 GMT) 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 Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg Scientific Title of A Double-Blind, Balanced, Randomized, Single dose, Parallel arm, Placebo controlled study to Study determine the Pharmacokinetics of Vitamin C Sustained ReleaseTablets 500 mg Manufactured by Inventia Healthcare Ltd in Healthy, Adult, Human Subjects Under Fasting Conditions. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name DR Rsenthurselvi Trial Coordinator (multi-center study) 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 [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name DR Rsenthurselvi Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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 page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Coimbatore Tamil Nadu India Coimbatore TAMIL NADU 641029 India Phone 0422-2642491 Fax 0422-2642492 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Inventia Healthcare Limited Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DrRSenthurSelvi Spinos Life Science No 29 A Krishna 0422-2642491 and Research Private Madhuravanam 0422-2642492 Limited Vellakinarpirivu senthurselvi.r@spinoslif Thudiyalur Coimbatore escience.com No 29 A Krishna Madhuravanam Vellakinarpirivu Thudiyalur Coimbatore Coimbatore Coimbatore TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Research Ethics Approved 26/01/2021 Yes Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Under Fasting Conditions. Intervention / Type Name Details Comparator Agent Intervention Vitamin C Sustained Release Manufactured by Inventia Tablets 500 mg 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 page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in 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. 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. Inclusion Criteria 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:<br/> • Subjects who agree to abstain from all vitamin C rich food / fruits etc. at least 15 days before the study.<br/> • 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).<br/> • Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.<br/> • Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.<br/> • 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.<br/> • Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.<br/> • Non-smokers or ex-smokers. Ex-smokers are page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in defined as someone who has completely stopped smoking for at least the past 03 months.<br/> • Willing to comply to all requirements of this study protocol as well as instructed by the study personnel.<br/> • Generally healthy as documented by gynecological examination and breast examination (for female subjects).<br/> • Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.<br/> • Female subjects of childbearing potential;<br/> • 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<br/> • Surgically sterile (bilateral tubal ligation).<br/> Exclusion Criteria Exclusion Criteria 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.