None listed
Conditions
Interventions
Intervention1: Tablet C3 Reduct 140 mg: 140 mg dose, single dose in one period, oral route of administration and single dose with 7 days washout period between each dose.
Manufactured and distributed
Sponsors
Sabinsa Europe GmbH
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. All study participants must provide a voluntarily written and signed Informed Consent document to participate in the study. 2. Healthy, non-smoking, non-alcoholic, adult, human volunteer (Male and female (non-pregnant, non-lactating) aged 18 to 45 years. 3. Volunteer with a BMI between 18.5 kg/m2 and 29.9 kg/m2 (inclusive of both) and weight 50 kgs for male and 45 kgs for female volunteers. 4. Healthy according to the laboratory results and physical examination, performed at the time of screening. 5. Volunteer must have a normal renal function (Serum Creatinine up to 1.2mg/dL). 6. Volunteer must be willing to avoid foods containing curcumin and black pepper for at least 60 hours before dosing of each period. 7. Volunteers must have a normal 12-lead electrocardiogram (ECG). 8. Volunteers must have normal chest X- Ray (P/A view). 9. A negative urine screen result for drugs of abuse. 10. A negative alcohol breath or urine test result. 11. Volunteers able to communicate effectively. 12. A negative serum beta hCG test result for female volunteers. 13. Male participant agreeing to use appropriate contraceptive measures like double barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam) and should not donate sperm during the study and for 07 days following last dose of the study medication. 14. If the study participant is a female and is of child bearing potential, she must practice an acceptable method of birth control for the duration of the study and for 07 days following last dose of the study medication as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: Or Is postmenopausal for at least 1 year. Or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study volunteer).
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Curcumin or any of the excipients in the formulation. 2. History or presence of any medical condition or disease according to the opinion of the physician. 3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 4. Difficulty with donating blood or difficulty in accessibility of veins. 5. Difficulty in swallowing tablets. 6. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in. 7. An unusual or abnormal diet within 48.00 hours prior to study check-in, for whatever reason e.g., because of fasting due to religious reasons. 8. Use of St. Johns wort 3 weeks prior to study check-in and during the study. 9. Volunteers who had planned for any surgery during the course of the trial. 10. History or current diagnosis of any cancer. 11. History of gall bladder issues. 12. Volunteer with hyperacidity. 13. Volunteer with gastric/duodenal ulcers. 14. Volunteer with prior use of prescription H2 blockers, proton pump inhibitors, or blood sugar lowering agents. 15. Volunteer who are using CYP3A4 and CYP1A2 inhibitors (e.g., statins, antihypertensives, certain chemotherapeutics). 16. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg. 17. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. 18. Pulse rate less than 60 beats/minute or more than 100 beats/minute. 19. Respiratory rate less than 14 breaths per minute or more than 18 breaths per minute. 20. Major illness in the past 90 days before screening. 21. Use of any prescribed medication or OTC medication during last two weeks or 5 half-life of that particular drug whichever is higher before dosing and unwilling to follow throughout the study and for 07 days following last dose of the study medication. 22. Consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, and caffeine-containing sodas, colas, etc.), grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study. 23. Participation in any clinical study within past 90 days. 24. Donation of blood in the past 90 days prior to study check-in of Period-I. 25. In case of Female participants Pregnant or lactating Women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the oral bioavailability of Tablet C3 Reduct 140 mg, Tablet Curcumin C3 Complex 500 mg and Tablet C3 Reduct 400 mg in healthy adult human (male and female) subjects under fed conditionsTimepoint: The blood samples will be collected at 0.00, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00 and 24.00 hours after drug administration in each period to evaluate the bioavailability. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Tablet C3 Reduct 140 mg, Tablet Curcumin C3 Complex 500 mg and Tablet C3 Reduct 400 mg in healthy adult human (male and female) subjects under fed conditions.Timepoint: Vital signs (body temperature, pulse rate, blood pressure and respiratory rate), assessment of health and well-being shall be recorded. 1.Before check-in of each period. 2.Before dosing in each period. 3.01.00, 03.00 and 07.00 hours after dosing in each period. 4.Before check-out of each period and/or withdrawal or at termination of the study. | — |
Countries
India
Contacts
Public ContactDr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
Outcome results
None listed