A clinical trial study to determine the oral bioavailability of curcuminoid capsules.
- Registration Number
- CTRI/2021/05/033903
- Lead Sponsor
- Pharmabase SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Normal healthy human adult subjects of age 18-45 years with BMI between 18.5 kg/m2 to 29.99 kg/m2
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.
Willing to consume ova lacto vegeterian diet
Evidence of allergy or known hypersenstivity to curcumin or its inactive ingredients.
Renal or liver impairment.
Any disease or condition which might compromise the haemopoeitic, 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 Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) tobacco containing products for at least 48.00 hours prior to check-inand throughout the entire study.
Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 72.00 hours prior to check-inand throughout the entire study.
History difficulty in swallowing, accessibility of veins.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method