To evaluate bioavailability study of curcumin micro emulsion soft gel Capsules 500 mg with Curcumin c3 complex® 500 mg capsules in healthy, adult human subjects under Fasting conditions.
- Registration Number
- CTRI/2022/03/041166
- Lead Sponsor
- Amitojas Wellness Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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).
10.Female subjects within normal limits or clinically non-significant laboratory
evaluation results for FSH.
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.
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, amphetamine AMP, 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 <br/ ><br>capsules 500 mg Manufactured by Geltec Pvt Ltd, India with Curcumin C3 <br/ ><br>complex® 500 mg Capsules, Manufactured by Doctors best. Inc, USA, in <br/ ><br>healthy, adult, human subjects under fasting conditions.Timepoint: 12 days of period
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of a single dose administered in <br/ ><br>healthy human adult subjects under fasting conditions. <br/ ><br>Timepoint: 48 hours