Bioavailability study in healthy male participants Other
Conditions
Interventions
Eligible participants will be randomized using a software-based randomization scheme (SAS software 9.4), assigned to either Test or Reference groups, and will be administered with either intervention
Melatonin 5 mg tablets manufactured by Nature made® will be used as reference. In each period, participants will be maintained to fast at least 10 hours prior to dosing and 4 hours post dosing. A sin
4 ml each) will be collected from each participant.
Sponsors
Sichuan Credit Pharmaceutical Co., Ltd, China
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who were healthy adult humans aged between 18 years and 45 years inclusive 2. Subjects who had a body mass index between 18.50 kg/m² and 25.00 kg/m² inclusive, and a body weight not less than 50 kg 3. Subjects who had normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests during screening 4. Subjects who had a normal 12 lead electrocardiogram (ECG) 5. Subjects who had a normal chest X ray (posteroanterior view), taken not more than 180 days prior to check in of Period 01 6. Subjects who were able to communicate effectively 7. Subjects who were willing to provide written informed consent and adhere to all requirements of the protocol 8. Subjects who were non smokers or moderate smokers, defined as not more than 9 cigarettes or beedis per day 9. Subjects who were non alcoholic or without any history of alcohol abuse, defined as more than 14 drinks per week, where 1 drink equals 360 mL beer, 150 mL wine, or 45 mL hard liquor
Exclusion criteria
Exclusion criteria: 1. Subjects who had a contraindication or hypersensitivity to the study drug or related group of drugs 2. Subjects with an unusual or abnormal diet for any reason within 48.00 hours prior to admission of each period, for example fasting due to religious reasons 3. Subjects with a history of hypertension 4. Subjects with a history of dehydration from diarrhoea, vomiting, or any other reason within 24.00 hours prior to admission to each study period 5. Subjects with positive results for drugs of abuse including benzodiazepines, cocaine, opioids, amphetamines, cannabinoids, or barbiturates in urine during admission to each study period 6. Subjects with positive results for alcohol consumption during admission to each study period 7. Subjects with intolerance to venipuncture 8. Subjects with a history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder 9. Subjects with a history or presence of any medical condition or disease, according to the opinion of the physician 10. Subjects with difficulty donating blood 11. Subjects with a major illness during the 90 days prior to Period I check in 12. Subjects who participated in a drug research study within the past 90 days prior to Period I check in 13. Subjects who donated blood, defined as one unit or 350 mL, within the past 90 days prior to check in 14. Subjects with difficulty swallowing solid dosage forms such as tablets 15. Female subjects were not included in the study
Countries
India
Contacts
Public ContactHitesh Shah
Outcome results
None listed