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A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product (15PCHB)

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ClinicalTrials.gov Identifier: NCT02474953
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Boston BioPharm
Information provided by (Responsible Party):
KGK Science Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Proprietary Curcumin Formulation Dietary Supplement: Unformulated Comparator Curcumin Product Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Dosing Sequence 1
Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second
Dietary Supplement: Proprietary Curcumin Formulation
Dietary Supplement: Unformulated Comparator Curcumin Product
Experimental: Dosing Sequence 2
Unformulated Comparator Curcumin Product administered first, Proprietary Curcumin Formulation administered second
Dietary Supplement: Proprietary Curcumin Formulation
Dietary Supplement: Unformulated Comparator Curcumin Product



Primary Outcome Measures :
  1. Curcumin AUC [ Time Frame: Time 0 to 48 hours ]
    Area Under the Curve

  2. Curcumin Cmax [ Time Frame: Time 0 to 48 hours ]
    Maximum Concentration

  3. Curcumin Tmax [ Time Frame: Time 0 to 48 hours ]
    Time until maximum concentration


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: Time 0 to 48 hours ]
  2. Changes in blood CBC levels [ Time Frame: Time 0 to 48 hours ]
  3. Changes in blood electrolyte levels [ Time Frame: Time 0 to 48 hours ]
  4. Changes in blood creatinine levels [ Time Frame: Time 0 to 48 hours ]
  5. Changes in blood AST levels [ Time Frame: Time 0 to 48 hours ]
  6. Changes in blood ALT levels [ Time Frame: Time 0 to 48 hours ]
  7. Changes in blood GGT levels [ Time Frame: Time 0 to 48 hours ]
  8. Changes in blood bilirubin levels [ Time Frame: Time 0 to 48 hours ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and females 18-45 years of age
  2. 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
  3. BMI 18-29.9 kg/m2 (±1 kg/m2)
  4. Healthy as determined by laboratory results and medical history
  5. Agrees to maintain current level of physical activity throughout the study
  6. Agree to avoid using black or white pepper, turmeric, curcumin or curry in the preparation of food for 7 days prior to randomization and throughout the study period.
  7. Agree to avoid Indian and Thai cuisines for the period of the study
  8. Agree to avoid food with yellow dye #E100
  9. Agrees to avoid alcohol, caffeine 12 hours and grapefruit and grapefruit juice 48 hours prior to baseline and each subsequent clinic visit
  10. Agrees to consume only low polyphenols in the diet (nutritionists will counsel on high polyphenol fruits, vegetables to avoid, wine, beer, supplements, herbal extracts, and whole-grain based foods) 3 days prior to baseline and on test days (meal options and lists of foods to avoid will be provided to subjects by nutritionists)
  11. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  1. BMI ≥ 30 kg/m2
  2. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
  3. Unstable medical conditions as determined by the Qualified Investigator
  4. Use of natural health products containing turmeric or curcumin within 7 days prior to randomization and during the course of the study
  5. Use of St Johns Wort 3 weeks prior to baseline and during the study
  6. Subjects who are smokers
  7. Subjects with current or history of gastrointestinal problems or disease
  8. Metabolic, endocrine, or chronic diseases
  9. Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
  10. 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
  11. Subjects who have planned surgery during the course of the trial
  12. History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable.
  13. History of gallbladder issues, hyperacidity, gastric/duodenal ulcers.
  14. Prior use of prescription H2 blocker, proton pump inhibitor or blood sugar-lowering agents
  15. Use of blood pressure medication
  16. Subjects on restrictive dietary regimens
  17. Blood donation in the last 2 months
  18. History of blood/bleeding disorders or taking prescription blood thinners or anti-platelet therapy
  19. Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
  20. Use of medical marijuana
  21. Clinically significant abnormal laboratory results at screening
  22. Participation in a clinical research trial within 30 days prior to randomization
  23. Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study
  24. Individuals who are cognitively impaired and/or who are unable to give informed consent
  25. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474953


Locations
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
Boston BioPharm
Investigators
Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.

Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02474953     History of Changes
Other Study ID Numbers: 15PCHB
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by KGK Science Inc.:
Curcumin
Pharmacokinetic

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action