None listed
Conditions
Interventions
Intervention1: Curcuminoids Formulation I - ACTIF PLUS (500 mg capsule containing Not Less Than 250 mg of curcuminoids/ capsule): Two capsules (500mg) to be taken only once at randomization visit.
Con
Sponsors
Bernd-Michael Loffler Institute for mitochondrial medicine
MOLECULES BIOLABS PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Normal, healthy, adult, Human Male participants of age between 18-45 years with a Body Mass Index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2 2. Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit 3. Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 21 days of check-in. 4. Subjects generally healthy considered by the physician or principal/clinical investigator to clinically, as documented by 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. 5. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months. 6. Willing to consume standard breakfast. 7. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 8. No consumption of Curcumin in a washout period of 14 days before the pharmacokinetic study
Exclusion criteria
Exclusion criteria: 1. Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients. 2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease. 3. Any major illness in the last three months or any significant ongoing chronic medical illness. 4. 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. 5. History of alcohol addiction or abuse. 6. Malabsorption syndrome that affects Curcumin metabolism. 7. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with mor than 100 per min ventricular rate. 8. Gastrointestinal bleeding in the past three months. 9. Uncontrolled diabetes mellitus. 10. Active psychiatric disorder, intention for suicide, disorders with Unconsciousness. 11. Psychopathic disorder, lack of cooperation. 12. Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months) 13. Taking more than 500 mg curcumin daily within 2 weeks to screening. 14. 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 dosing and throughout the entire study 15. Consumption of alcohol and its products, grapefruit and/or its juice and poppy containing foods for at least 72.00 hours prior to dosing and throughout the study. 16. Subjects should not take any over the counter medicinal products, herbal medications within 07 days prior to study check in and throughout the study and any prescription medications within 14 days prior to study check-in and throughout the study. 17. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period. 18. An unusual or abnormal diet within 48.00 hours prior to study dosing of each period, for whatever reason e.g., because of fasting due to religious reasons. 19. Subject who had participated in any other study within the 90 days of check-in. 20. History of difficulty in swallowing. 21. History of difficulty in accessibility of veins. 22. Positive results for alcohol breath test prior to check-in of each period 23. Any blood donation / excess blood loss within 90 days of check-in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the relative bioavailability of (T1) Actif plus (500 mg capsule containing NLT 250 mg of curcuminoids/ capsule) of Institute for Mitochondrial Medicine, and (T2) Actif (500 mg capsules which contains 250 mg of curcuminoids) of Institute for Mitochondrial Medicine in healthy, adult, male subjects under fed conditions.Timepoint: Enrollment day. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor adverse events and to ensure the safety of the subjects.Timepoint: Screening visit and End of study. | — |
Countries
India
Contacts
Public ContactShalini Dayananda
Unitree Health Care Diagnostics
Outcome results
None listed