None listed
Conditions
Interventions
Intervention1: Doctors Best Curcumin 1000 mg Hard Capsule 2 X 500mg: Single oral dose of Curcumin 100mg Hard capsules Will Be Administered in each period 10 Days Duration
Control Intervention1: Cocrys
Sponsors
Cocrystal Health Industry Zhejiang Co Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy adult human male and or female subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 30.00 kg per 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 are considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as do cumented by the medical history including vitamins and dietary supplements physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet All subjects will be instructed to have all meals free of turmeric starting at least 07 days before period I till the end of period II and all in house meals will also be given free of turmeric Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Curcumin 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 Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and /or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and 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 48 00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications vitamins and dietary supplements 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 study check in and throughout the study Subjects who have taken any unusual diet for whatever reason eg low salt for 48 00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check-in History of difficulty in swallowing History of difficulty in 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 the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females are likely to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioavailability of Crysvital Curcumin 1000 mg Hard Capsule (2 X 500mg) Manufactured by Wei Hai Sai Rui Space Technology Co Ltd No 175 2 Dong an Road, Economic and Technological Development Zone Weihai City Shandong Province China with Doctors Best Curcumin 1000 mg Hard Capsule (2 X 500mg) Manufactured by 18100 Von Karman Avenue Suite 800 Irvine CA 92612 United State In Healthy Adult Human Subjects Under Fasting ConditionsTimepoint: 15 Time Points -12 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 24 00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy, adult, human subjects under fasting conditionsTimepoint: 15 Time Points -12 00 hrs 00 00 hrs 00 50 hrs 01 00 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 24 00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed