NCT03146273已完成不适用
A Pharmacokinetic Crossover Comparison Study of Absorption Characteristics of Two Multivitamin Mineral Formulations (Gel vs. Tablet/Capsule)
Galilee CBR1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年5月9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
- 20
- 试验地点
- 1
- 主要终点
- Mean fractional absorption
研究概览
简要总结
This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals defined in the protocol
详细描述
This clinical study is designed to evaluate difference in the AUC of the absorption of Multivitamin and minerals:
- Tablet/capsule administration - up to 20 healthy volunteers will be recruited to the study. The tablet/capsule will be administered as a single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
- Gel administration - the gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. The participants will be monitored during 6 hours for the level of minerals and Multivitamin minerals in the blood, adverse events and vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female and aged 18-65 years
- •BMI - 19-24
- •Subject is not pregnant and is not nursing
- •Signed Informed Consent Form
排除标准
- •Current use of multivitamin or mineral complexes (washout of 4 days before Visit 2 is permitted)
- •Participants with known vitamins or mineral deficiencies
- •Diabetes Type II
- •Subjects who have undergone surgery within the last 3 months.
- •Subjects with a clinically significant (during last 3 months) infectious, immune-mediated or active malignant disease.
- •Subjects who are receiving an elemental diet or parenteral nutrition.
- •Subjects who are treated with insulin.
- •Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
- •Subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
- •Known sensitivity to any ingredients in the study product
- •History of addiction or drug abuse
- •Alcoholic regular use
结局指标
主要结局
Mean fractional absorption
时间窗: 6 hours
A comparison of mean fractional absorption of the two Multivitamin mineral formulations (gel vs. tablet/capsule).
次要结局
- Absorption rate(6 hours)
研究者
研究点 (1)
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