None listed
Conditions
Interventions
Intervention1: Capsaicinoids capsules 50 mg: Oral Dose
Capsules
One time
Intervention2: Capsaicinoids Capsules 25 mg: Oral Dose
Capsules
One time
Control Intervention1: Cayenne Capsules 250 mg: Oral
Sponsors
Dr Shefali Thanawala
Eligibility
Inclusion criteria
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 all requirements for this study protocol as well as instructed by the study personnel
Exclusion criteria
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 Xanthiine containing products cigarette and tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the oral pharmacokinetic properties of capsaicinoids 50 and 20 mg capsulesTimepoint: 23 00.00, 00.25, 00.50, 00.75.1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 Hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolrability of capsaicinoids capsulesTimepoint: 23 00.00, 00.25, 00.50, 00.75.1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 Hours | — |
Countries
India
Contacts
Public ContactDr K Annamalai MBBS MBA Msc
Spinos Lifescience and Research Pvt Ltd
Outcome results
None listed