None listed
Conditions
Interventions
Intervention1: Product C (Turmeric Extract 95% (1800 mg total curcuminoids): Turmeric Extract 95% (1800 mg total curcuminoids) equally divided in six capsules as 300 mg total curcuminoids/ capsule. CU
Sponsors
OmniActive Health Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy, adult, human subjects within the age range of >=18 to 55 years. • Subjects with a BMI between 20.0-27.0 Kg/m2 • Participation is truly voluntary Subjects should avoid food containing curcumin, black pepper at least 48 hrs before dosing. • Absence of disease markers of HIV 1 & 2, hepatitis B & C virus. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history, physical examination and systemic examination during the screening A normal 12-lead ECG A normal chest X-ray (PA view) done within past 6 months. Subjects have to be weight stable (weight change Compliance with the requirement of the entire protocol Subjects able to communicate effectively Subjects willing to give written informed consent and adhere to all the requirements of this protocol Subject is a non-smoker and non-alcoholic Additional inclusion criteria for female subjects:- Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: or Postmenopausal for at least 1 year, or, Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
Exclusion criteria
Exclusion criteria: Institutionalized subjects. History or evidence of hypersensitive to curcumin or its metabolites. History or presence of any medical condition or disease according to the opinion of the physician. History or evidence of chronic diseases such as diabetes, hypertension, metabolic syndrome, liver disorders, kidney disorders, pulmonary disease or infections,cardiovascular disease, pancreatic disease, infectious diseases, dermatological problems, arthritis and any cancer. History of hypo and hyperthyroidism. Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding,unintentional weight loss, anemia, dysphagia, or abdominal mass. History of milk, gluten allergies or other known food intolerances and or any food allergies. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash. Exclusion of subjects taking ace- inhibitors, cholesterol lowering medications. Subjects participating in aerobic exercise more than three times per week. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day)consumption. History of difficulty with donating blood or difficulty in accessibility of veins. History of addiction to any recreational drug or drug dependence. Systolic blood pressure less than 90 mm Hg or more than 130 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 80 mm Hg. Pulse rate less than 60 beats per minute or more than 100 beats per minute. Donation of blood (i.e. one unit or 350 mL) in the past 90 days before check-in. Participation in a clinical research study within past 90 days of check-in. Receipt of any prescription drugs or over-the-counter drugs (e.g.: cold preparations antacid preparations and natural products used for therapeutic benefits) within 30 days prior to screening. Use of supplements containing curcumin or its metabolites 30 days prior to period I dosing and during the study duration. Major illness during 90 days before check-in. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to check-in of period. An unusual or abnonnal diet within 48.00 hours prior to check-in of each period, for whatever reason e.g. because of fasting due to religious reasons. Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study. Consumption of food and beverages containing xanthine (chocolates, tea, coffee or cola drinks) for at least 48.00 hours prior to check-in of each period. Consumed grapefruit and grapefruit like citrus fruit (mosumbi/sweet lime) or juice within the 7 days prior to check-in of each period. Positive results for drugs of abuse (benzodiazepi nes, opioids, amphetamines, cannabinoids, cocaines and barbiturates) in urine during the check-in of each period. • Positive results for urine alcohol analysis during the check-in of each period. • Difficulty in swallowing solids dosage forms like tablets or capsules. Additional exclusion criteria for female subjects, Volunteer demonstrating a positive pregnancy test. Volunteers who arc pregnant, currently breast-feeding or who are likely to become pregnant during the study. Volunte
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative absorption will be calculated using AUC values for Product A compared with Product C and Product B compared with Product CTimepoint: Pk samples will be collected at -4.00,0.00,0.50,1.00,2.00,3.00,4.00,5.00,6.00,8.00,10.00,12.00, and 24.00 hours after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjects.Timepoint: -4.00,0.50,1.00,2.00,3.00,4.00,5.00,6.00,8.00,10.00,12.00,24.00 | — |
Countries
India
Contacts
Public ContactKVMadhusudhan
ClinSync Clinical Research Pvt.Ltd
Outcome results
None listed