To evaluate bioavailability study of curcumin micro emulsion soft gel Capsules 500 mg with Curcumin c3 complexÂ® 500 mg capsules in healthy, adult human subjects under Fasting conditions.

Not yet recruiting

Conditions: ADULT HUMAN SUBJECTS UNDER FASTING CONDITIONS

Registration Number: CTRI/2022/03/041166

Lead Sponsor: Amitojas Wellness Pvt Ltd

Brief Summary: The curcumin exhibits poor bioavailability is well documented. The major reasons attributed to the low bioavailability of curcumin are poor absorption, rapid metabolism, and rapid systemic elimination. In humans a comprehensive pharmacokinetic data do not exist. The pilot studies summarized that low systemic bioavailability is observed in humans following oral dosing. First phase I clinical trial of curcumin was done in 25 patients with high-risk or pre-malignant lesions. The starting dose was 500 mg/day and if no toxicity was noted, the dose was then escalated to another level in the order of 1,000, 2,000, 4,000, 8,000, and 12,000 mg/day. There was no treatment-related toxicity up to 8 g/day but the bulky volume of the drug was unacceptable to the patients beyond 8 g/day. The serum concentration of curcumin usually peaked at 1 to 2 hours after oral intake of curcumin and gradually declined within 12 hours. The average peak serum concentrations after taking 4,000 mg, 6,000 mg and 8,000 mg of curcumin were 0.51 +/âˆ’ 0.11 Î¼M, 0.63 +/âˆ’ 0.06 Î¼M and 1.77 +/âˆ’ 1.87 Î¼M, respectively. Urinary excretion of curcumin was undetectable. Lao et al conducted a pilot study in 24 healthy subjects and they administered curcumin up to 12g/day. They detected curcumin in the serum samples of only those who took 10 and 12g/day. It was reported that a daily oral dose of 3.6g of curcumin results in detectable levels in colorectal tissue, which might be sufficient to exert pharmacological activity. Curcumin undergoes metabolism in the liver particularly via glucuronidation and sulfation. The metabolites of curcumin such as glucoronides appear to lack any pharmacological activity.The systemic elimination of curcumin is another contributing factor for low bioavailability of curcumin. The initial reports by Wahl storm and Blennow showed that after oral administration of 1g/kg curcumin to rats, more than 75% of curcumin was excreted in feces and negligible amount was detected in urineIncrease the bioavailability of curcumin, is also being explored. The roles of adjuvant, which can block the metabolism of curcumin, are of great interest. Combining curcumin with Piperine has been shown to increase the bioavailability in rats and in human subjects. Piperine is an inhibitor of glucuronidation of curcumin. The study conducted by Shobha et al demonstrated that concomitant administration of curcumin with Piperine produced 150% increase in bioavailability in rats and 2000% increase in man. Other ways to improve the bioavailability of curcumin is by making curcumin nanoparticles micelles and phospholipid complexes.The possible advantages attributed to such formulations are (a) Provide longer circulation (b) Increase the cellular permeability and (c) Induce resistance to metabolic processes.Systemic elimination or clearance of curcumin from the body is an important factor determining its biological activity. Wahlstorm and Blennow reported that, when 1 g/kg curcumin was given orally to rats, 75% was excreted in the feces and negligible amounts were found in the urine. A clinical study of 15 patients receiving oral curcumin in doses between 36 and 180 mg daily for up to 4 months found neither curcumin nor its metabolites in urine, but the drug was recovered from feces. The absorption and elimination half-life of orally administered curcumin (2 g/kg) in rats were reported to be 0.31 0.07 and 1.7 0.5 h, respectively. However, the same dose of curcumin in humans did not allow the calculation of these half-life values because serum curcumin levels were below detection limits at the majority of time points in most of the experimental patients. Existing evidence in the literature is insufficient to draw conclusions about the factors controlling the in vivo elimination half-life of curcumin, and future studies are warranted to address this issue [7].

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

1.Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 (according to the formula of BMI weight (kg) or[height (m)]2) 2.Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.
3.Subjects whose screening laboratory values are within normal limits or considered by the physician or principal or clinical investigator to be of no clinical significance.
4.Healthy as documented by the 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.Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
6.Non- smokers or ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
7.Willing to consume Ovo lacto vegetarian diet.
8.Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
9.Generally healthy as documented by gynecological examination and breast examination (for female subjects â€“ period I only).
11.Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study and a negative urine pregnancy test prior to check-in of each period.
12.If subject is female; currently not pregnant, not lactating, or not attempting to become pregnant for 4 weeks before the screening visit, throughout the duration of the study and 3 weeks after the subjectâ€™s last study-related visit (for eligible subjects only, if applicable), has a negative pregnancy test, and is of non-childbearing potential, defined as: 1 year post-menopausal (no menstrual period for at least 12 consecutive months without any other medical cause) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or is of childbearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study: double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) intrauterine device (IUD) with a low failure rate less than 1 percent per year or is of childbearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active.
13.If male and sexually active, the subject is willing to commit to 2 acceptable methods of birth control for the duration of the study.
14.The subject and their partners are willing to use 2 types of contraception, one of which is a barrier method, such as the use of a condom throughout the study.

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 and pre-existing gallbladder disease.
Any major illness in the last three months or any significant ongoing chronic medical illness.
3.Renal or liver impairment.
4.Any disease or condition which might compromise the hemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
5.History of alcohol addiction or abuse.
6.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 check-in and throughout the entire study.
7.Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 72.00 hours prior to check-in and throughout the entire study.
8.Subjects who have taken any prescription medications 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 check-in and throughout the study.
9.Subjects who have taken an unusual diet, for whatever reason (e.g. low salt) for 48.00 hours prior to check-in and throughout the study.
10.Subject who had participated in any other study within the 90 days of check-in.
11.History of difficulty in swallowing.
12.History of difficulty in accessibility of veins.
13.Positive results for urine screen of drugs of abuse (Marijuana-THC, amphetamineAMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of each period.
14.Positive results for alcohol test prior to check-in of each period.
15.Any blood donation / excess blood loss within 90 days of check-in.
16.Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
17.Use of hormone replacement therapy for a Period of 06 months prior to dosing.
18.Female subjects demonstrating a positive pregnancy screen.
19.Female subjects who are currently lactating.
20.Females likely to become pregnant during conducting of the study.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the oral Bioavailability of Curcumin micro emulsion soft gel	12 days of period
capsules 500 mg Manufactured by Geltec Pvt Ltd, India with Curcumin C3	12 days of period
complexÂ® 500 mg Capsules, Manufactured by Doctors best. Inc, USA, in	12 days of period
healthy, adult, human subjects under fasting conditions.	12 days of period

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability of a single dose administered in	healthy human adult subjects under fasting conditions.

Trial Locations

Locations (1): Spinos Lifescience and Research Pvt Ltd
🇮🇳
Coimbatore, TAMIL NADU, India
Spinos Lifescience and Research Pvt Ltd
🇮🇳Coimbatore, TAMIL NADU, India
Dr Annamalai
Principal investigator
8637620087
annamalai.k@spinoslifescience.com