A clinical trial study to determine the bioavailability of different formulations of curcumin tablets.

An open-label, balanced, randomized, single-dose, two-treatment, two-period, two-way crossover, relative bioavailability study of two different formulations of Curcumin 10 mg orally soluble tablet manufactured by KMS Health Center Pvt. Ltd., East Tambaram, Selaiyur, Chennai and Curcunex G 5 mg manufactured by Stabicon Life Science Pvt. Ltd., Plot No 28, Bommasandra industrial area (Sub layout), 4th Phase, Jigani Hobli, Anekal Taluk, Bangalore, Karnataka- 560100. Marketed by Yeus Life science Pvt Ltd, A-IO, Art gold house, Lbs Marg, Mumbai 400070 in healthy, adult, human, male subjects under fasting conditions.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034356

Enrollment

Registered

2021-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

None listed

Interventions

Intervention1: Curcumin 10 mg tablets: Single dose - 10 mg tablet Oral route Control Intervention1: Curcunex G 5mg: Single dose - 5 mg Oral route

Eligibility

Inclusion criteria

Inclusion criteria: Normal, healthy, adult, human male subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21days 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. Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments. Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.

Exclusion criteria

Exclusion criteria: Evidence of allergy or known hypersensitivity 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-in 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 check-in and throughout the entire study. History difficulty in swallowing, 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.

Design outcomes

Primary

Measure	Time frame
To assess the Relative Bioavailability of different formulations of Curcumin tablets in healthy adult human male subjects under fasting conditions.Timepoint: 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours.	—

Secondary

Measure	Time frame
To monitor the safety and tolerability of a single dose administered in healthy adult human male subjects under fasting conditions.Timepoint: 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00,10.00, 12.00 and 24.00 hours.	—

Countries

India

Contacts

Public ContactDr Senthurselvi MBBS MD

Spinos Lifescience and Research Pvt Ltd.

senthurselvi.r@spinoslifescience.com

Outcome results