Bioequivalence Study on Vitamin C in Healthy Adults

Inclusion Criteria

• BMI 18.5 to 29.9 kg/m2 (+/- 1 kg/m2)
• Healthy as determined by laboratory results and medical history
• Maintains current level of physical activity throughout duration of study
• Does not donate blood for the next 3 months after completing study
• Avoidance of foods and beverages fortified with vitamin C for at least 7 days prior to enrollment and duration of study
• Avoidance of citrus foods, citrus juices, and tomato juice for at least 7 days prior to enrollment and duration of study
• Non smoker or ex-smoker > 1 year
• Has given voluntary, written informed consent to participate in study
• Agrees to avoid high caffeine and alcohol intake 72 hours prior to in-clinic test days and during the 24-hour in-clinic test days
• Females not of child bearing potential, defined as having had a hysterectomy, oophorectomy, bilateral tubal ligation or are post-menopausal
• Females of child bearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods include hormonal contraceptives, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) and/or vasectomy of partner

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 tri