| CTRI Number |
CTRI/2025/10/096666 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Single Dose Three Period Oral Bioequivalence Study Comparing Melatonin 2 mg Prolonged Release Tablets In Healthy Adult Human Subjects Under Fasting Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Partial Replicate Reference scaled Average Oral Bioequivalence Study Comparing Melatonin 2 mg Prolonged Release Tablets Manufactured by V S International Pvt Ltd India with Circadin Melatonin 2 mg Prolonged Release Tablets Marketing Authorization Holder RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux 75002 Paris France In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0023-25-MELA Version No 01 Date 29 Apr 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 pirivu Thudiyalur Coimbatore
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 pirivu Thudiyalur Coimbatore
Coimbatore
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 pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| V S International Pvt Ltd A 204 Neelam Center Hind Cycle arg
Worli Mumbai 400030 India |
|
|
Primary Sponsor
|
| Name |
V S International Pvt Ltd |
| Address |
A 204 Neelam Center Hind Cycle arg
Worli Mumbai 400030 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 Lifescience and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committe ECR/84/lndt/TN/2013/RR-24 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Circadin Melatonin 2 mg Prolonged Release Tablets Marketing Authorization Holder RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux 75002 Paris France |
A Single oral dose of Circadin Melatonin 2 mg Prolonged Release Tablets will be administered in each period Total Duration is 12 days |
| Intervention |
Melatonin 2 mg Prolonged Release Tablets Manufactured by V S International Pvt Ltd India |
A Single oral dose of Melatonin 2 mg Prolonged Release Tablets will be administered in each period Total Duration is 12 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 30.00 kg/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/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
Willing to comply with all requirements of this study protocol as well as instruction from the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only
Females of childbearing 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 subject’s last studyrelated visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
non-childbearing potential defined as
1 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 Melatonin or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder diseas 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 ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to checkin 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 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 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 compare the rate and extent of absorption of single dose of Melatonin 2 mg Prolonged Release Tablets Manufactured by V S International Pvt Ltd India with Circadin Melatonin 2 mg Prolonged Release Tablets Marketing Authorization Holder RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux 75002 Paris France In Healthy Adult Human Subjects Under Fasting Conditions |
30 Time points
-24 00 hrs -20 00 hrs -16 00 hrs -12 00 hrs -10 00 hrs 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 09 00 hrs 10 00 hrs 12 00 hrs 18 00 hrs and 24 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 |
30 Time points
-24 00 hrs -20 00 hrs -16 00 hrs -12 00 hrs -10 00 hrs 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 09 00 hrs 10 00 hrs 12 00 hrs 18 00 hrs and 24 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
23/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| 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
|
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.
Note: If needed the study will be conducted as batch wise.
Standard meals will be provided starting -35.00, -23.00, -20.00,
-16.00 and -12.00 pre-dose hours for each period
Standard meals will be provided at 04.00, 08.00 and 12.00 hours
post-dose respectively (within +30 minutes of scheduled time). All meal plans
will be identical in all the periods of the study
In each period, after an overnight fasting of at least 10.00 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
The subjects will fast for at least 10.00 hours prior to dosing and
04.00 hours post-dose.
Blood pressure, radial pulse rate, body temperature and wellbeing
status will be enquired and recorded at pre-dose -21.00, -17.00 hours (±60
minutes) and 00.00 hour (within 75 minutes of before dosing) and at 01.00,
03.00, 06.00 and 11.00 hours (±60 minutes) post-dose.
Physical examination and vitals will be recorded before check-in,
check-out (24.00 hours (± 60 minutes)) for each period and at any time if
necessary
Monitoring for adverse events will be done throughout the study
period in clinical phase
|