An Open-Label, Balanced, Randomized, Single-Dose, Four-Treatment, Four-Period, Four- Sequence, Four-Way Crossover Study of Oral Bioavailability ofSundalp/Micellon, in Healthy, Adult, Human Subjects Under Fasting Conditions.

Not Applicable

• Registration Number: CTRI/2022/02/040335
• Lead Sponsor: Pharmabase SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Volunteers meeting all of the following criteria will be considered for enrollment in the study:

Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg per m2 to 29.99 kg per m2. 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 Ova lacto vegetarian diet.

Willing to comply with all requirements of this study protocol as well as instructed by the study 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 the principal investigator; and/or

Surgically sterile (bilateral tubal ligation)

Exclusion Criteria

Volunteers with history or significant presence of the following will be excluded from

participation/enrollment in the study:

Evidence of allergy or known hypersensitivity to Curcuminor 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 check-inand 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 check-in and throughout the entire study.

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.

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.

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 each period.

Positive results for alcohol 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 who are currently lactating.

Females likely to become pregnant during conducting of the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified