Bioequivalence Study on Vitamin C in Healthy Adults

Exclusion Criteria

• •Women who are pregnant, breast feeding, or planning to become pregnant during the trial
• •Duodenal or gastric ulcer, gastritis, hiatus hernia, or GERD within past 3 months
• •History of irritable bowel syndrome and related disorders
• •Significant gastrointestinal disease (includes but not limited to Celiac disease)
• •History of malabsorption
• •Unstable medical conditions as determined by the Qualified Investigator
• •Blood pressure greater than 150/90 mmHg
• •Cancer except skin cancers completely excised with no chemotherapy or radiation following and with a negative follow up. (Volunteers with cancer in full remission for more than 4 years after diagnosis are acceptable)
• •Clinically significant abnormal laboratory results at screening
• •Metabolic disease or chronic diseases (ex/ hyperlipidemia, hypertension, hypercholesterolemia)
• •Type I or Type II diabetes
• •History of kidney stones
• •Use of prescription or over the counter products known to interact with vitamin C within 72 hours of enrollment and duration of trial such as aspirin and NSAIDs, aluminum, iron, and proton pump inhibitors
• •Use of acute over the counter medication within 72 hours of test product dosing
• •Use of tobacco products within the last year
• •More than 2 alcoholic drinks per day
• •Drug abuse within 1 year of enrollment
• •Use of medicinal marijuana
• •Immunocompromised individuals such as individuals that have undergone organ transplantation or individuals diagnosed with HIV
• •Individuals who have planned surgery during the course of the trial
• •St. John's wort in the last 30 days prior to enrollment and duration of study
• •Use of vitamin C, multivitamins containing vitamin C, or foods or beverages fortified with vitamin C and other natural healthy products containing vitamin C within 7 days of enrollment and duration of study
• •Consumption of citrus foods, citrus juices, and tomato juice with 7 days of enrollment and duration of study
• •Use of anticoagulants, barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
• •Use of natural health products/dietary supplements with 7 days of enrollment or duration of study
• •Current diagnosis and history of blood/bleeding disorders
• •Current diagnosis and history of anemia of any etiology defined as hemoglobin \< 145 g/L for males and \< 123 g/L for females
• •History of hemoglobinopathies such as sickle cell anemia or thalassemia, sideroblastic anemia
• •History of hemochromatosis
• •Blood donation in the past 3 months
• •Individuals who plan to donate blood during the study or within 30 days of completing the study
• •Participation in a clinical research trial within 30 days prior to enrollment
• •Allergy or sensitivity to supplement ingredients or to any food or beverage provided during the study
• •Individuals who are cognitively impaired and/or who are unable to give informed consent
• •Any other condition which in the Qualified Investigator's opinion nay adversely affect an individual's ability to complete the study or its measures or which may pose significant risk to the individual