Bioequivalence Study on Vitamin C in Healthy Adults

Completed · Not applicable

Conditions studied: Dietary Exposure

In brief

The objective of this exploratory pharmacokinetic research study is to demonstrate that both caplets and gummies provide an effective dose of ascorbic acid in healthy adults.

Key facts

Study ID

NCT03562988

Run by

Church & Dwight Company, Inc.

People needed

35

Starts

2017-08-01

Expected to finish

2017-12-22

Last updated by the study team

2021-08-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Church & Dwight Co., Inc. — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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