To study the safety of curcumin capsules

Not Applicable

Completed

Registration Number: CTRI/2023/10/058584

Lead Sponsor: GeneVec

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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 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

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. (All meals free of turmeric, cumin and black pepper and any related marketed spice mixtures)

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 and Piperine 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 ongoing chronic medical illness

Renal or liver impairment

History of alcohol addiction or abuse

Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, Or any other body system, presence of Diabetes Mellitus and Psychosis.

Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) cigarettes and tobacco containing products including tobacco mixed masala, pan, pan masala, gutkha, supari (betel nut) etc.,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 48.00 hours prior to check-in and throughout the entire study

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

Subjects who have taken an unusual diet for whatever reason (e.g. low salt) for 48.00 hours prior to check-in and throughout the study

Subject who had participated in any other study within the 90 days of check-in

History of 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

Positive results for alcohol test prior to check-in of each period

Any blood donation/excess blood loss within 90 days of check-in

Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in

Use of hormone replacement therapy for a Period of 06 months prior to dosing