Oral comparative study of melatonin capsules

Not Applicable

Completed

• Registration Number: CTRI/2022/08/044837
• Lead Sponsor: Dr Shefali Thanawala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-07
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Normal healthy adult human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 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 or 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 may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments

Generally healthy as documented by 12-lead electrocardiogram (ECG) X-Ray and clinical laboratory assessments.

Non-smokers or ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.

Willing to consume Ovo lacto vegetarian diet.

Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.

Generally healthy as documented by gynaecological examination and breast examination (for female subjects ââ?¬â?? period I only).

Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH.

Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period.

If 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 subjectââ?¬•s last study-related visit (for eligible subjects only, if applicable), has a negative pregnancy test.

If male and sexually active, the subject is willing to commit to 2 acceptable methods of birth control for the duration of the study.

The subject and their partners are willing to use 2 types of contraception, one of which is a barrier method, such as the use of a condom throughout the study.

Exclusion Criteria

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 on going chronic medical illness.

Renal or liver impairment.

Any disease or condition which might compromise the hemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.

History of alcohol addiction or abuse.

Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarette and 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 check-in and throughout the entire study.

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.

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 check-in and throughout the study.

Subjects who have taken an unusual diet, for whatever reason (e.g. low salt) for 48.00 hours prior to check-in and throughout the study.

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 start of 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 likely to become pregnant during conducting of the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the Pharmacokinetic of Melotime Capsules (Melatonin SR Granules 11 mg equivalent to 5 mg Melatonin)Timepoint: 20 <br/ ><br>00.00, 00.25,00.50,00.75,01.00,01.33,01.67,02.00,02.33, 02.67, 03.00, <br/ ><br>04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 14.00 and 24.00 HoursGranules 11 mg equivalent to 5 mg Melatonin)

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability of a single dose administered m <br/ ><br>heahhy human aduh subjects under fasting conditions.Timepoint: 20 <br/ ><br>00.00, 00.25,00.50,00.75,01.00,01.33,01.67,02.00,02.33, 02.67, 03.00, <br/ ><br>04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 14.00 and 24.00 Hours