A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product

KGK Science Inc.1 site in 1 country12 target enrollmentApril 2015

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: KGK Science Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Curcumin AUC
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is investigating the pharmacokinetic profile (i.e. the way the product is processed by the body) of a proprietary curcumin formulation compared to an unformulated curcumin product. Subjects will take a single dose of either the proprietary formulation or comparator product and the blood levels of curcumin and curcumin metabolites will be measured over a period of 48 hours.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

KGK Science Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and females 18-45 years of age
•If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) OR
•Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
•Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
•Double-barrier method
•Non-hormonal intrauterine devices
•Vasectomy of partner
•BMI 18-29.9 kg/m2 (±1 kg/m2)
•Healthy as determined by laboratory results and medical history
•Agrees to maintain current level of physical activity throughout the study

Exclusion Criteria

•BMI ≥ 30 kg/m2
•Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
•Unstable medical conditions as determined by the Qualified Investigator
•Use of natural health products containing turmeric or curcumin within 7 days prior to randomization and during the course of the study
•Use of St Johns Wort 3 weeks prior to baseline and during the study
•Subjects who are smokers
•Subjects with current or history of gastrointestinal problems or disease
•Metabolic, endocrine, or chronic diseases
•Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
•Clinically significant abnormal lab results at screening (e.g. AST and/or ALT \> 2 x ULN, and/or bilirubin \> 2 x ULN) will be assessed by the Qualified Investigator