None listed
Conditions
Interventions
Intervention1: Caffein: Dose : 200 mg Dosage form :Capsule Route of administration: Oral duration: After overnight fasting for at least 10 hours.
Intervention2: Paraxanthine: Dose : 200 mg Dosage form
Sponsors
M/S. INGENIOUS INGREDIENTS
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects must be healthy human male and female 50 percentage each subjects 2 Age should be between 18 to 45 years of age both inclusive weighing at least 50 kg 3 BMI less than 30 kg per m2 4 Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol 5 Subjects willing to give consent for CYP1A2 genotyping 6 Subjects with no evidence of underlying disease during the pre study screening They must be healthy as determined by medical history and physical examination ECG Chest X ray PA View and laboratory tests performed within 7 days prior to the commencement of the study 7 Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance
Exclusion criteria
Exclusion criteria: 1 Subject has a known allergy or sensitivity to any ingredient in the test product 2 Subject with resting hypotension BP less than 90 per 60 or hypertension BP more than 140 per 90 and pulse rate below 50 per min and more than 100 per min 3 Subject with or a prior history or presence of significant cardiovascular pulmonary hepatic renal hematological gastrointestinal endocrine immunologic dermatologic neurological musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in housing. 4 Subjects with a history of MI Stroke Peripheral Arterial Disease GI Bleeding Hepatic Impairment Asthma Renal Impairment Epilepsy and Intracranial hemorrhage 5 Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study 6 Subjects who are hypersensitive to Heparin 7 Subjects who participated in any other clinical study in the past three months 8 Subject with clinically significant abnormal lab values or abnormal ECG or abnormal Chest X-ray PA View 9 Subject who has difficulty with donating blood 10 Subject with history of difficulty in swallowing 11 Subject who has unsuitable veins for repeated venipuncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the bioavailability of Paraxanthine (PX) and Caffeine (CF) in plasma by LC-MS/HPLC.Timepoint: 0 min, 10min, 20min, 40min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr and 24hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of the test product on overall mood through caffeine research visual analogue scale (Caff-VAS)Timepoint: Day 0 and Day 1 of Period 1, 2 & 3;Changes in blood parameters assessed by blood tests: Hematology, Biochemistry and Urine analysisTimepoint: Screening, Day 0 and Day 1 of Period 1, 2 & 3 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed