None listed
Conditions
Interventions
Intervention1: Curcuminoids longa extract Formulation 60% (200 mg)
manufactured by Chemiloids Life Sciences Private Limited, India: Name of the Intervention: Curcuminoids longa extract Formulation 60%
Sponsors
Chemiloids Life Sciences Private Limited.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy human volunteers aged 18-45 years and weighing at least 50 kg. 2.Capable and willing to give informed written consent and adhere to study requirements. 3.BMI between 18.50 30.00 kg/m . 4.Healthy individuals based on personal history, medical history, and general medical examination. 5.No significant disease as judged by the investigator. 6.Normal biochemical, hematological, and urinary parameters, or clinically insignificant abnormalities (within 21 days prior to Period I check-in). 7.Normal 12-lead ECG or clinically insignificant abnormalities. 8.Negative for HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody, and VDRL. 9.Negative urine screening for drugs of abuse (Cannabinoids, Amphetamine, Barbiturates, Cocaine, Benzodiazepines, Morphine). 10.Negative breath alcohol test. 11.Non-smoker. 12.Non-alcoholic. 13.Ability to fast for at least 10 hours prior to dosing and 4 hours after dosing. 14.Ability to consume standard meals. 15.Ability to consume turmeric-free and black pepper-free food. 16.Willingness to adhere to protocol requirements and provide written informed consent. 17.Can provide adequate evidence of identity. For Female Volunteers: 12. Negative pregnancy tests 13. Not pregnant, lactating, or attempting pregnancy 14. Use of contraception if sexually active and of childbearing potential
Exclusion criteria
Exclusion criteria: 1.History of any significant medical disorder as determined by the investigator. 2.History of any major surgical procedure within the past 3 months. 3.History of being on dialysis. 4.History or presence of significant hematopoietic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urinary retention, severe gastrointestinal condition, myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia, or psychiatric disorder. 5.History or presence of diabetes mellitus, tuberculosis, or systemic hypertension. 6.History or current use of medication for joint pain, inflammation, kidney stones, or urinary tract issues. 7.Recent history of dehydration due to diarrhea, vomiting, or any other cause within 24 hours prior to check-in. 8.History of dysphasia. 9.History or presence of cancer. 10.Difficulty in donating blood. 11.Personal or family history of muscular disorders. 12.Any deformity affecting venous access for cannulation. 13.History or presence of significant medical disorders as determined by the investigator. 14.History of alcohol consumption. 15.Habituation to coffee, tea, or other xanthine-containing products and inability to withhold intake. 16.Consumption of caffeine and/or xanthine products (e.g., coffee, tea, chocolate, caffeine-containing sodas) within 24 hours prior to check-in. 17.Consumption of tobacco-containing products, grapefruit, and its juice within 48 hours prior to check-in. 18.Positive breath test for alcohol or urine scan for drug abuse during check-in. 19.History of drug abuse. 20.History of allergy to vegetables, food substances, or any other hypersensitivity reactions. 21.Current or past use of medications that may modify the kinetics/dynamics of study medications or other medications deemed clinically significant by the investigator. 22.Participation in a drug research study or blood donation within 90 days prior to check-in. 23.Positive screening test result for HIV, Hepatitis B, Hepatitis C, or VDRL. 24.Intake of OTC products, herbal medications, or similar within 7 days prior to check-in. 25.Intake of prescription medications within 14 days prior to check-in that may affect the study medications. 26.Unusual diet (e.g., low sodium) within 3 weeks prior to check-in. 27.Depot injection or drug implant within 3 months prior to study commencement. 28.Following a vegan diet. 29.History of hypersensitivity to study medications, related medications, or excipients in the formulation. 30.Consumption of food containing curcumin or black pepper within 48 hours prior to dosing. 31.History or evidence of hypersensitivity to curcumin, Piperine, or their metabolites. 32.Any blood donation or excessive blood loss within 90 days of check-in. For Female Volunteers: 33. Pregnant or lactating females, those planning to become pregnant, donate gametes during the study, or unwilling to use appropriate contraceptive methods during the study and for 3 weeks after the last study-related visit. 34. Female volunteers with a positive urine pregnancy test at screening, and a positive serum pregnancy test before check-in for each period and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the comparative pharmacokinetic profile and bioavailability of a single oral dose of the Test Product (T) Curcuminoids Formulation 60% (200 mg) Manufactured by Chemiloids Life Sciences Private Limited, India with Reference Product (R) Curcuminoids unformulated 95% (1000mg) anufactured by Chemiloids Life Sciences Private Limited, India in Healthy, Adult, Human Subjects under Fasting ConditionsTimepoint: In each period, total of 11 (1 x 06 mL) blood samples will be collected from each subject in K2EDTA vacutainers. The blood samples will be collected at 00.00 (pre-dose) within 02.00 hours prior to dosing and the post dose blood samples will be collected 00.50, 01.00, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single oral dose administered in Healthy, Adult, Human Subjects Under Fasting Condition.Timepoint: Medical examination: During screening, Before check-in of each period, Before check-out of each period and / or at termination of study. Vitals (Blood Pressure, Radial Pulse, Respiratory Rate and Body Temperature) and Well-being recording: During screening, Before check-in of each period, Before drug administration (within 02.00 hours prior to dosing) of each period. Prior to checkout of each period. At 01.00, 02.00, 06.00 and 12.00 hours (within 40 minutes of the scheduled time) post dose in each period. | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
BioRadius Therapeutic Research Pvt. Ltd.
Outcome results
None listed