CTRI

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CTRI Number

CTRI/2024/09/073804 [Registered on: 12/09/2024] Trial Registered Prospectively

Last Modified On:

25/11/2024

Post Graduate Thesis

Type of Trial

BA/BE

Type of Study

Study Design

Randomized, Crossover Trial

Public Title of Study

Scientific Title of Study

An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Crossover Partial Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Melatonin 2 Mg Prolonged Release Tablets Manufactured By Vs 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-0057-24-MELA Version No 01 Date 01 Jul 24	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pradeep T
Designation	Principal Investigator
Affiliation	Spinos Life science and research private limited
Address	Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore Coimbatore TAMIL NADU 641029 India
Phone	8220586899
Fax
Email	pradeep.t@spinoslifescience.com

Details of Contact Person
Scientific Query

Name	Dr Pradeep T
Designation	Principal Investigator
Affiliation	Spinos Life science and research private limited
Address	Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore Coimbatore TAMIL NADU 641029 India
Phone	8220586899
Fax
Email	pradeep.t@spinoslifescience.com

Details of Contact Person
Public Query

Name	Dr Pradeep T
Designation	Principal Investigator
Affiliation	Spinos Life science and research private limited
Address	Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore Coimbatore TAMIL NADU 641029 India
Phone	8220586899
Fax
Email	pradeep.t@spinoslifescience.com

Source of Monetary or Material Support

V S International Pvt Ltd A 204 Neelam Center Hind Cycle Marg Worli Mumbai 400030 India

Primary Sponsor

Name	V S International Pvt Ltd
Address	A 204 Neelam Center Hind Cycle Marg Worli Mumbai 400030 India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Spinos Life Science and research Private Limited	Door No 29A Krishna Maduravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu

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 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore TAMIL NADU	8220586899 pradeep.t@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

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Fasting Condition

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Circadin Melatonin prolonged release 2 mg Tablets	Circadin Melatonin 2 mg Prolonged Release Tablets administered as single oral dose in fasting condition in each period
Intervention	Melatonin 2 mg prolonged release Tablets	Melatonin 2 mg Prolonged Release Tablets administered as single oral dose in fasting condition in each period

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 Normal healthy adult human subjects of age between 18 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 diet 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

ExclusionCriteria

Details

Volunteers with a history or significant presence of the following will be excluded from participation/enrollment in the study
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 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 ie 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 an unusual diet for whatever reason 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 this study 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 compare the rate and extent of absorption of single dose of Melatonin 2 mg Prolonged Release Tablets	22 blood samples -24.00 hrs -20.00 hrs -16.00 hrs -12.00 hrs -10.00 hrs 00.00 hrs 00.33 hrs 00.67 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 05.00 hrs 06.00 hrs 08.00 hrs 10.00 hrs 12.00 hrs 14.00 hrs and 24.00 hrs

Secondary Outcome

Outcome	TimePoints
To evaluate the safety and tolerability of a single dose of Melatonin 2 mg prolonged release tablets in healthy adult human subjects under fasting conditions	22 blood samples -24.00 hrs -20.00 hrs -16.00 hrs -12.00 hrs -10.00 hrs 00.00 hrs 00.33 hrs 00.67 hrs 01.00 hrs 01.50 hrs 02.00 hrs 02.50 hrs 03.00 hrs 03.50 hrs 04.00 hrs 05.00 hrs 06.00 hrs 08.00 hrs 10.00 hrs 12.00 hrs 14.00 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)

27/09/2024

Date of Study Completion (India)

Date Missing

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)
Modification(s)

Completed

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

Enough volunteers shall be recruited in order to evaluate and start the study with at least 48 subjects, as this Bioequivalence study will be conducted on healthy, adult, human subjects.

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.

Study can be conducted by dividing the study subjects into groups. The subject number in the study will be allocated sequentially in each group

In each period subjects will be housed in the clinical facility for at least 36.00 hours pre-dose to 24.00 hours post-dose, with a washout period of at least 04 days from the successive dosing day.

Lighting will be standardized. Melatonin is not produced endogenously in presence of ambient light. This standardization including using same windowless room on the dosing day and will be maintained over the entire blood sampling period. Lighting in the room will be kept constant. All light readings are between 500 lux and 600 Lux. Four light meter readings will be recorded on each study periods. (in the morning 07:00 AM to 08:00 AM, in the afternoon 12:00 PM to 01:00 PM, in the evening 05:00 PM to 06:00 PM and in the night 11:00 PM to 12:00 AM).

Note: Light readings will be recorded by using Luxmeter.