Open-label, Randomized Comparator Study for Evaluation the Bioavailability of "Novo C Plus" Vitamin C Containing Dietary Supplement in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma ascorbic acid concentration area under curve
研究概览
简要总结
The aim of this study is to evaluate the bioavailability of "Novo C Plus" vitamin C containing dietary supplement compared to licensed vitamin C medications. The novelty of this product is the liposomal formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-65 years old healthy volunteers
- •body weight >45 kg
- •body height >150 cm
- •plasma ascorbic acid at screening <75 µmol/l
- •signed written informed consent
- •subject agrees avoid vitamin C containing medications and dietary supplements from screening until V0 visit (maximum 15 days)
- •subject agrees to avoid high activity physical exercise 72 hours prior to V0 visit
排除标准
- •confirmed or suspected active infection
- •liver or renal failure (equal or greater than CKD3)
- •chronic disease that affects absorption or vitamin C metabolism
- •severe metabolic disorder
- •body mass index >35 kg/m2
- •malabsorption syndrome that affects vitamin C metabolism
- •heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with >100/min ventricular rate
- •gastrointestinal bleeding in past three months
- •uncontrolled diabetes mellitus (HbA1c>8,5%)
- •malignant disease
- •alcohol or drug abuse
- •active psychiatric disorder, intention for suicidal, disorders with unconsciousness
- •psychopathic disorder, lack of cooperation
- •known coagulopathy
- •chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
- •untreated hypertension if blood pressure is greater than 165/95 mmHg
- •gravidity or breastfeeding
- •taking more than 100 mg vitamin C daily within 2 weeks to screening
研究组 & 干预措施
600 mg Novo C plus
Single dose of oral 600 mg Novo C plus dietary supplement (contains 600 mg ascorbic acid in liposomal formulation)
干预措施: Ascorbic Acid (Drug)
900 mg Novo C Plus
Single dose of 900 mg oral Novo C plus dietary supplement (contains 900 mg ascorbic acid in liposomal formulation)
干预措施: Ascorbic Acid (Drug)
500 mg intravenous vitamin C
Single dose of 500 mg intravenous ascorbic acid (Vitamin C 100 mg/ml injection; EGIS)
干预措施: Ascorbic Acid (Drug)
500 mg oral vitamin C
Single dose of 500 mg oral ascorbic acid (Cetebe 500 mg retard capsules; GlaxoSmithKline Consumer Healthcare - GSK Export)
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Plasma ascorbic acid concentration area under curve
时间窗: 360 minutes
Plasma ascorbic acid concentration will be measured from peripheral blood samples after 30-45-60-90-120-180-240-300-360 minutes after getting the medication. Area under curve of time - plasma concentration curve will be calculated.
次要结局
- Safety and tolerability assessed by number of subjects with treatment-related adverse events as assessed by CTCAE v4.0(24 hours)
- Urine ascorbic acid excretion(12 hours)
研究者
Istvan Takacs
Reader in university
Semmelweis University