A clinical trial study to determine the oral bioavailability of curcuminoid capsules.

An Open-Label, Balanced, Randomized, Single-Dose, Four Treatment, Four Period, Four Sequence, Four Way Crossover Study of Oral Bioavailability of Sundalp/Micellon Standardized To Min. 2.25% Curcuminoids Capsules 500 mg1 Soft gel Capsule of Manufactured By Sferalp SAVia Cantonale 77, CH-6998 Monteggio, Switzerland T1, Sundalp/ Micellon Standardized To Min. 2.25% Curcuminoids Capsules 2000 Mg 4*500 mg Soft gel Capsules of Manufactured By Sferalp SA Via Cantonale 77, CH-6998 Monteggio, Switzerland T2 with Curcumin Phytosome 500 Mg Turmeric Rhizome Extract Curcuma Longa Phosphatidyl Choline Complex Meriva Turmeric PhytosomeStandardized To Min. 18% Curcuminoids 90 Mg 1 Capsule Manufactured By Now Foods 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA R1, Jigsaw Health Curcumin C 3 Complex 500 Mg NLT 95% Total Curcuminoids Curcuma Longa Rhizomes 1 Capsule Manufactured By Jigsaw Health LLC 9035 E Pima Center Pkwy Suite 4 Scottsdale AZ 85258 USA R2 - In Healthy, Adult, Human Subjects Under Fasting Conditions

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033903

Enrollment

Registered

2021-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sundalp Micellon capsule T1: Single dose -500 mg capsule Oral route standardized to minimum 2.25% curcuminoids(Duration- one month) Intervention2: T2 2000 mg capsules: single dose 2000

Eligibility

Inclusion criteria

Inclusion criteria: Normal healthy human adult subjects of age 18-45 years with BMI between 18.5 kg/m2 to 29.99 kg/m2 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. Willing to consume ova lacto vegeterian diet

Exclusion criteria

Exclusion criteria: Evidence of allergy or known hypersenstivity to curcumin or its inactive ingredients. 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-inand throughout the entire study. History difficulty in swallowing, accessibility of veins.

Design outcomes

Primary

Measure	Time frame
To determine the oral bioavailability of different formulations of curcuminoids in healthy, adult, human subjects under fasting conditions.Timepoint: 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00 and 36.00 hours	—

Secondary

Measure	Time frame
To monitor the safety and tolerability of a single dose administered in healthy human adult subjects under fasting conditionsTimepoint: 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.33, 02.67, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00 and 36.00 hours	—

Countries

India

Contacts

Public ContactDr Senthurselvi R

MBBS MD

senthurselvi.r@spinoslifescience.com

Outcome results