A SINGLE-DOSE, TWO-TREATMENT, TWO-PERIOD STUDY OF TWO DIFFERENT FORMULATONS OF CURCUMIN 10 MG ORALLY SOLUBLE TABLET AND CURCUNEX G 5 Mg IN HEALTHY, ADULT, HUMAN, MALE SUBJECTS UNDER FASTING CONDITIONS.
- Registration Number
- CTRI/2021/03/031895
- Lead Sponsor
- KMS Health Center Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
Healthy, adult, human male volunteers of age between 18-45 years
1.Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients.
2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse and recently overcome or active existing tinnitus.
3.Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
4.Any major illness in the last three months or any significant ongoing chronic medical illness.
5.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.
6.History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine, barbiturates, THC and amphetamine etc.).
7.History of alcohol addiction or abuse.
8.History of difficulty in swallowing.
9.History of difficulty in accessibility of veins.
10.Any blood donation / excess blood loss within 90 days of check-in.
11.Subject who had participated in any other study within the 90 days of study check-in.
12.Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study.
13.Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study.
14.Use of any prescribed medication within 14 days and any over the counter medicinal products, herbal medications, etc. within 07 days prior to study check in and throughout the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method