None listed
Conditions
Interventions
Intervention1: Melatonin 2 mg prolonged release Tablets: Melatonin 2 mg Prolonged Release Tablets administered as single oral dose in fasting condition in each period
Control Intervention1: Circadin M
Sponsors
V S International Pvt Ltd
Spinos Life Science and research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of single dose of Melatonin 2 mg Prolonged Release TabletsTimepoint: 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
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single dose of Melatonin 2 mg prolonged release tablets in healthy adult human subjects under fasting conditionsTimepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed