| CTRI Number |
CTRI/2025/08/093119 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Single Dose Four Period Study Comparing Diclofenac Sodium Tablet 100 mg In Healthy Adult Human Subjects Under Fed Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Fully Replicate Reference scaled Average Oral Bioequivalence Study Comparing Diclofenac Sodium Sustained Release Tablet 100 mg manufactured by Unique Pharmaceutical Laboratories A Division of J B Chemicals & Pharmaceuticals Ltd Plot No 218 219 GIDC Industrial Area Panoli 394 116 Gujarat with VOLTAREN SR Diclofenac Sodium Film Coated Tablet 100 mg manufactured by Novartis Farma SPA Torre Annunziata Italy In Healthy Adult Human Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0043-25-DICL Version No 01 Date 12 May 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Unique Pharmaceutical Laboratories A Division of J B Chemicals and Pharmaceuticals Ltd Neelam Center B Wing 4th Floor Hind Cycle Road Worli Mumbai 400 030 India |
|
|
Primary Sponsor
|
| Name |
Unique Pharmaceutical Laboratories |
| Address |
A Division of J B Chemicals and Pharmaceuticals Ltd Neelam Center B Wing 4th Floor Hind Cycle Road Worli Mumbai 400 030 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore641029 Tamil Nadu India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Life science and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee RegistrationNoECR/84/Indt/TN/2013/RR-24 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed Conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac Sodium Sustained Release Tablets 100 mg |
A Single oral dose of Diclofenac Sodium Sustained Release Tablets 100 mg will be administered ineach period Total Duration is 25 Days |
| Comparator Agent |
VOLTAREN SR 100 mg Diclofenac Sodium film-coated tablet |
A Single oral dose of Diclofenac Sodium Sustained Release Tablets 100 mg will be administered ineach period Total Duration is 25 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human male and female subjects of age between 18 to 45 years and BodyMass Index BMI ranges between 18.50 kg per m2 to 29.99 kg per m2
Subjects who have no evidence of underlying disease during screening and check in and whosescreening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits are considered by the physicianor principal or clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but not limited to anevaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervoussystem and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinicallaboratory assessments
Willing to consume Ovo lacto-vegetarian diet
Willing to comply with all requirements of this study protocol as well as instructions from the studypersonnel
Non smokers
Generally healthy, as documented by gynaecological examination and breast examination period Ionly
Females of childbearing potential must have a negative serum pregnancy test performed within 21days prior to the initiation of the study and a negative urine pregnancy test prior to check in foreach period
If the subject is female currently not pregnant not lactating or not attempting to become pregnantfor 4 weeks before the screening visit throughout the duration of the study and 3 weeks after thesubjects last study related visit for eligible subjects only if applicable has a negative serumpregnancy test and is of
non-childbearing potential defined as
greater or equal to 01 year post menopausal no menstrual period for at least 12 consecutivemonths without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
childbearing potential willing to commit to using a consistent and acceptable method of birth controlas defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film withspermicide
intrauterine device IUD with a low failure rate of less than 1 percentage per year
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptablemethod of birth control as defined above for the duration of the study in the event the subjectbecomes sexually active |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Diclofenac or its inactive ingredients
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 that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or xanthine containing products i.e. coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48:00 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 within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study
Subjects who have taken any unusual diet for whatever reason eg low salt 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 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 each period
Positive results for alcohol test prior to check-in of each period
Any blood donation or excess blood loss within 90 days of check in
Ingestion of any hormonal agent at any time within 14 days prior to the start of the 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
Females are likely to become pregnant during the course of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Diclofenac Sodium Sustained Release Tablets 100 mg manufactured by Unique Pharmaceutical Laboratories A Division of J B Chemicals & Pharmaceuticals Ltd Plot No 218 219 GIDC Industrial Area Panoli 394 116 Gujarat with VOLTAREN SR 100 mg Diclofenac Sodium film coated tablet manufactured by Novartis Farma SPA Torre Annunziata Italy In Healthy Adult Human Subjects Under Fed Conditions |
23 Time Points
00 00 hrs 00 50 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fed conditions |
23 Time Points
00 00 hrs 00 50 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/08/2025 |
| 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="6"
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
|
At least 36 number of healthy, adult, human subjects will be recruited to evaluate the Bioequivalence of Test product with the Reference product As per the discretion of the Investigator a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 36 subjects in period I alone Note If needed the study may be conducted as batch wise In each period subjects will be housed in the clinical facility for at least 11 00 hours pre dose to 48 00 hours post dose with a washout period of at least 07 days from the successive dosing day In each period after an overnight fasting of at least 08.00 hours in the morning high fat high calorie non veg breakfast will be provided 30 minutes before dosing After consumption of breakfast a single oral dose of either the test product or reference product will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour within 75 minutes of before dosing and at 01.00 02.00 04.00 06.00 12.00 and 24.00 hours (±60 minutes) post dose ECG will be recorded before check out 48.00 hours for each period and if any subject is withdrawn or dropped out during the study |