MedDRA version: 21.1 Level: LLT Classification code 10023190 Term: Jet lag System Organ Class: 100000004852
Conditions
Interventions
Product Name: Melatonin 1 mg/ml oral solution
Product Code: N/A
Pharmaceutical Form: Oral solution
INN or Proposed INN: melatonin
CAS Number: 73-31-4
Current Sponsor code: N/A
Other descriptive name:
Sponsors
Aspire Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Negative test results of SARS-CoV-2 RT-PCR test. 2. Healthy human volunteers between 18 and 45 years of age (both inclusive) living in and around the city of Zagreb. 3. Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in meter. 4. Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, and 12 Lead ECG. 5. Able to understand and comply with the study procedures, in the opinion of the Principal investigator. 6. Volunteer who is currently a non-smoker 7. Able to give voluntary written consent for participation in the trial. 8. In case of female subjects: • Surgically sterilized at least 6 months prior to study participation Or • If of child bearing potential: is willing to use a suitable and effective double barrier contraceptive method. And • Serum Pregnancy test must be negative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Positive test results of SARS-CoV-2 RT-PCR test. 2. Known hypersensitivity or idiosyncratic reaction to Melatonin or to any of its excipients or any related drug or any substance. 3. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 4. Ingestion or use of any medication (prescribed and over the counter (OTC) medication including herbal remedies) at any time in 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator. 5. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. 6. Consumption of Grapefruits or its products within a period of 24 hours prior to receiving the study drug of period-I. 7. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and 07 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine. 8. Smokers, or who have smoked within last six months prior to start of the study. 9. The presence of clinically significant abnormal laboratory values during screening. 10. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 11. History or presence of psychiatric disorders. 12. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within 90 days prior to receiving the dose in this study. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study. Note: In case the blood loss was less than or equal to 200 mL; subject may be dosed 60 days after blood donation or after the last sample of previous study 13. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. A positive test result for HIV antibody (I and II). 14. An unusual diet, for whatever reason (e.g. low-sodium), for four week prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator. 15. Nursing mothers (females).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Characterization of the bioavailability and pharmacokinetic profile of the Sponsor's test product Melatonin 1 mg/ml oral solution;Secondary Objective: Monitoring of the safety of the subjects;Primary end point(s): Cmax, AUC0-t, AUC0-8, Tmax, ?z, t1/2, and AUC_%Extrap_obs.;Timepoint(s) of evaluation of this end point: Time schedule 01h before dosing 30 min before dosing Within 05 minutes prior to dosing 10 min after the dosing 15 min after the dosing 20 min after the dosing 30 min after the dosing 40 min after the dosing 01h after the dosing 02h after the dosing 03h after the dosing 04h after the dosing 06h after the dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events which will be evaluated for duration, severity, seriousness and unexpectedness, action taken, date and time of resolution and association with the study treatment.;Timepoint(s) of evaluation of this end point: Throughout trial. | — |
Countries
Croatia
Contacts
Public ContactClinical Trials Inbox
Aspire Pharma Limited
Outcome results
None listed