| CTRI Number |
CTRI/2025/06/089166 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Single Dose Four Period Oral Bioequivalence Design In Healthy Adult Human Subjects Under Fasting 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 Mesalazine Gastro Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt Ltd with Salofalk 500 mg Mesalazine Gastro Resistant Tablets Marketing Authorization Holder Dr Falk Pharma GmbH Leinenweberstr 5 79108 Freiburg Germany In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0028-25-MESA Version.01 Protocol Date 18-Apr-2025 |
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 pirivuThudiyalurCoimbatore 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 pirivuThudiyalurCoimbatore 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 pirivuThudiyalurCoimbatore Coimbatore TAMIL NADU India
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Sunglow Lifescience Pvt. Ltd.
208/1A, 208/2A1B,220/3B,
Kattankulam Village (Nelvoy - Thirumukkoodal Road),
Uthiramerur (TK) Kanchipuram (Dt.), Pin: 631606,
Tamil Nadu, India
|
|
|
Primary Sponsor
|
| Name |
Sunglow Lifescience Pvt. Ltd |
| Address |
208/1A, 208/2A1B,220/3B,
Kattankulam Village (Nelvoy - Thirumukkoodal Road),
Uthiramerur (TK) Kanchipuram (Dt.), Pin: 631606,
Tamil Nadu, 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 Coimbatore641029Tamil 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 Lifescience andResearch privatelimited |
Clinical Pharmacology unit GroundFloor No 29 AKrishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore 641029 CoimbatoreTAMIL NADU
Coimbatore
TAMIL NADU
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research EthicsCommittee RegistrationNoECR/84/Indt/TN/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mesalazine Gastro-Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt. Ltd |
A Single oral dose of Mesalazine Gastro Resistant Tablets BP 500 mg will be administered in each period Total Duration is 29 Days |
| Comparator Agent |
Salofalk® 500 mg (Mesalazine Gastro-Resistant Tablets) Marketing Authorization Holder: Dr. Falk Pharma GmbH, Leinenweberstr. 5, 79108 Freiburg, Germany |
A Single oral dose of Salofalk 500 mg Mesalazine Gastro Resistant Tablets will be administered in each period Total Duration is 29 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 Body Mass Index BMI ranges between 18.50 kg per m2 to 30 00 kg per m2
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 are considered by the physician or principal or clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments
Willing to consume ovo Lacto vegetarian diet
Willing to comply with all requirements of this study protocol as well as instructions from the study personnel
Non smokers
Generally healthy, as documented by gynaecological examination and breast examination period I only
Females of child bearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check in for each period
If the subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
non-childbearing potential defined as
greater or equal to 01 year post menopausal no menstrual period for at least 12 consecutive months 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 control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
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 acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Mesalazine or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuseexisting
Exclude Poor Metabolisers of CYP 2D6 Which is confirmed by carrying out the cytochrome P450 2D6 test
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 hepaticcardiovascularMusculoskeletal respiratory central nervous system or any other body systemincluding presence of DiabetesMellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and /or xanthine containing products ie coffee tea chocolate caffeinecontaining sodas colasetc cigarettes and tobacco containing products for at least 48.00 hours priorto check in and throughout the entirestudy
Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within48.00 hoursprior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications within 14 days prior to study check-in andthroughout thestudy and any over the counter medicinal products herbal medications within 07 daysprior to study check in andthroughout the study
Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior todosing andthroughout 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 barbituratesBAR cocaine COCbenzodiazepines 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 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 Mesalazine Gastro Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt Ltd with Salofalk 500 mg Mesalazine Gastro Resistant Tablets Marketing Authorization Holder Dr Falk Pharma GmbH Leinenweberstr 5 79108 Freiburg Germany In Healthy Adult Human Subjects Under Fasting Conditions |
24 Time points
00 00 hrs 03 00 hrs 04 00 hrs 05 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 09 00 hrs 10 00 hrs 10 50 hrs 11 00 hrs 11 50 hrs 12 00 hrs 12 50 hrs 13 00 hrs 13 50 hrs 14 00 hrs 15 00 hrs 16 00 hrs 18 00 hrs 20 00 hrs 24 00 hrs 36 00 hrs and 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 fasting conditions |
24 Time points
00 00 hrs 03 00 hrs 04 00 hrs 05 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 09 00 hrs 10 00 hrs 10 50 hrs 11 00 hrs 11 50 hrs 12 00 hrs 12 50 hrs 13 00 hrs 13 50 hrs 14 00 hrs 15 00 hrs 16 00 hrs 18 00 hrs 20 00 hrs 24 00 hrs 36 00 hrs and 48 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
26/09/2025 |
| Date of First Enrollment (Global) |
30/06/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
60 number of healthy, adult, human subjects will be
recruited to evaluate the Bioequivalence of Test product with the Reference
product.
The study will be conducted in Two stage.
STAGE 01:
At least 48 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 48 subjects in period I alone.
STAGE 02:
At least 12 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 12 subjects in period I alone.
Note:
Stage 02 will be conducted with 12 subjects in case of
requirement and the report will be prepared for 48 Subjects if stage 02 is not
conducted.
In each period subjects will be housed in the clinical
facility for at least -36.00 hours pre dose to 48.00 hours post dose
A washout period of at least 08 days will be maintained
between each dosing period
In each period, after an overnight fasting of at least 08.00
hours, in the morning a single oral dose of either the test product (T) or
reference product (R) 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 -21.00, -17.00 and
00.00 hour (within 75 minutes of before dosing) and at 03.00, 06.00, 12.00 and
24.00 hours (±60 minutes) post-dose
Monitoring for adverse events will be done throughout the
study period in clinical phase |