A clinical trial study to determine the bioavailability of different formulations of curcumin tablets.

Phase 1

Completed

Conditions: To monitor the safety and tolerability of a single dose administered in healthy adult human male subjects under fasting conditions

Brief Summary: Toassess the relative bioavailability of different Curcumin formulations and to monitor the safety andtolerability of a single dose administered in healthy adult human male subjectsunder fasting conditions.Employingthe estimated concentration vs. time profiles ofTotal Curcuminusing WinNonlinÂ® version 8.1 or higherversion of Pharsight Corporation, USA, or SASÂ® system for windows version 9.4 or above (SASÂ®Institute Inc., USA) or applicable software the following pharmacokineticparameters

**Primaryparameters are:** Cmax, AUC0-t & AUC0-Â¥.

**Secondary parameters are:** tmax,Kel, tÂ½.&

Statistical analyses for Total Curcumin (will bedone using R-Software or SASÂ® system for windows version 9.4 orabove (SASÂ® Institute Inc., USA).

Recruitment & Eligibility

Inclusion Criteria

Normal, healthy, adult, human male 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 21days 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.
Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.

Exclusion Criteria

Evidence of allergy or known hypersensitivity 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-in and 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-in and throughout the entire study.
History difficulty in swallowing, accessibility of veins.
Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of each period.

Primary Outcome Measures

Name	Time	Method
To assess the Relative Bioavailability of different formulations of Curcumin tablets in healthy adult human male subjects under fasting conditions.	00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours.

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability of a single dose administered in healthy adult human male subjects under fasting conditions.	00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours.

Locations (1): Spinos Lifescience and Research Pvt Ltd
🇮🇳
Coimbatore, TAMIL NADU, India
Spinos Lifescience and Research Pvt Ltd
🇮🇳Coimbatore, TAMIL NADU, India
Dr Senthurselvi R
Principal investigator
9750722032
senthurselvi.r@spinoslifescience.com