An Open-Label, Balanced, Randomized, Single-Dose, Four-Treatment, Four-Period, Four -Sequence, Four - Way Crossover Study Of Relative Bio availability Healthy, Adult, Human Subjects Under Fed Conditions.

Not yet recruiting

Conditions: Under fed condition

Registration Number: CTRI/2021/02/031263

Lead Sponsor: Institut fuer mitochondriale Medizin

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 systemic elimination of curcumin is another contributing factor for low bioavailability of

curcumin.

Existing evidence in the

literature is insufficient to draw conclusions about the factors controlling the in vivo elimination halflife of curcumin, and future studies are warranted to address this issue.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2(according to the formula of BMI weight (kg) / [height (m)]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.
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
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.
Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
Non- smokers or ex-smokers.
Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
Willing to consume standard breakfast.
Willing to comply to all requirements of this study protocol as well as instructed by thestudy personnel Generally healthy as documented by gynecological examination and breast examination (for female subjects â€“ period I only).
Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH.
Female subjects of childbearing potential; Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or Surgically sterile (bilateral tubal ligation).

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Curcumin or its inactive ingredients.
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.
Renal or liver impairment.
Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
History of alcohol addiction or abuse.
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 dosing and throughout the entire study.
Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 72.00 hours prior to dosing and throughout the entire study.
Subjects should not take any over the counter medicinal products, herbal medications within 07 days prior to study check-in and throughout the study and any prescription medications within 14 days prior to study check-in and throughout the study.
An unusual or abnormal diet within 48.00 hours prior to dosing of each period, for whatever reason e.g. because of fasting due to religious reasons.
Systolic blood pressure less than 90mrn Hg or more than 140mmHg and diastolic blood pressure less than 60 mmHg or more than 90 mmHg. Subject who had participated in any other study within the 90 days of check-in.
History of difficulty in swallowing.
History of difficulty in accessibility of veins.
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 this study period.
Positive results for alcohol breath test prior to check-in of each period.
Any blood donation / excess blood loss within 90 days of check-in.
Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in.
Use of hormone replacement therapy for a Period of 06 months prior to dosing.
Female subjects demonstrating a positive pregnancy screen.
Female subjects whose menstruation cycle coincides with the study periods Female subjects who are currently lactating.
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 evaluate the Relative Bioavailability Of the test product in healthy, adult, human subjects under fed conditions	21 days

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fed conditions.	21 days

Trial Locations

Locations (1): Spinos Life Science and Research Private Limited
🇮🇳
Coimbatore, TAMIL NADU, India
Spinos Life Science and Research Private Limited
🇮🇳Coimbatore, TAMIL NADU, India
Dr R Senthurselvi
Principal investigator
senthurselvi.r@spinoslifescience.com