NCT02292303已完成不适用
Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.
研究概览
简要总结
The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •Sex: female (premenopausal), male
- •Age: 20 - 50 years
- •BMI ≥19 or ≤30 kg/m²
- •Non-smoker
- •Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology
排除标准
- •Relevant history or presence of any medical disorder, potentially interfering with this trial
- •For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- •Migraine or regular headache, intense premenstrual symptoms
- •Coffee consumption >3 cups / day
- •Blood donation within 2 months prior to trial start or during trial
- •Regular intake of mineral supplements within 4 weeks prior to trial start or during trial
- •Chronic intake of substances affecting the intestinal absorption of zinc
- •Vegetarians / vegans
- •Drug-, alcohol- and medication abuses
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance
- •Known pregnancy, breast feeding or intention to become pregnant during the study
- •Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- •Not anticipating any planned changes in lifestyle for the duration of the study
研究组 & 干预措施
zinc-enriched yeast
Experimental
zinc-enriched yeast capsules
干预措施: zinc-enriched yeast (Dietary Supplement)
zinc oxide
Active Comparator
zinc oxide capsules
干预措施: Zinc references (Dietary Supplement)
zinc gluconate
Active Comparator
zinc gluconate capsules
干预措施: Zinc references (Dietary Supplement)
结局指标
主要结局
Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.
时间窗: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
次要结局
- Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate.(Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min)
研究者
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