NCT03562988已完成不适用
A Randomized, Examiner-blind, Comparator-controlled, Cross-over Bioequivalence Study on Vitamin C in Healthy Adults
Church & Dwight Company, Inc.2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Mean Plasma L-ascorbic Acid as Cmax
研究概览
简要总结
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.
详细描述
This randomized, examiner-blind, cross-over study evaluates the bioequivalence of a gummy containing vitamin C relative to a caplet comparator product in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Plasma L-ascorbic Acid as Cmax
时间窗: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
Mean Plasma L-ascorbic Acid as Cmax
Mean Plasma L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]
时间窗: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
Mean Plasma L-ascorbic Acid as Total Area Under the Curve \[AUC(0-24 hours)\]
Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve [AUC(0-24 Hours)]
时间窗: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
Mean Leukocyte L-ascorbic Acid as Total Area Under the Curve \[AUC(0-24 hours)\] for All Study Participants
Mean Leukocyte L-ascorbic Acid as Cmax
时间窗: baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours
Mean Leukocyte L-ascorbic Acid as Cmax
次要结局
- Mean Leucocyte Vitamin C Absorption Rate as Tmax(baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours)
- Mean Plasma Vitamin C Absorption Rate as Tmax(baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours)
研究者
研究点 (2)
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