NCT02183285已完成3 期
A 30 Day, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre Safety Trial to Evaluate the Tolerability Profile of Pharmaton PHL 00747 Soft Gelatine Capsules (Multivitamin, Multimineral + Omega-3 Fatty Acids) 1/Day p.o. and Pharmaton PHL 00747 Film-coated Tablets (Multivitamin, Multimineral Without Omega-3 Fatty Acids) 1/Day p.o. in Healthy, Young Female Subjects of Child-bearing Potential
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 主要终点
- Incidence of total drug-related adverse events assessed by the investigator
研究概览
简要总结
To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female out-patients of child-bearing potential
- •Ages ranging between 18 and 40 years
- •Willing and able to give written informed consent in accordance to Good Clinical Practice (GCP) and local legislation prior to participation in the study
排除标准
- •Contraindications to the use of any of the trial ingredients
- •Known hypersensitivity to any of the ingredients
- •Alcohol- or drug-addiction
- •Currently participation in another trial, or has participated in a trial within the previous 30 days
- •Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
- •Already taking other mult-vitamin products during the last 2 weeks
结局指标
主要结局
Incidence of total drug-related adverse events assessed by the investigator
时间窗: up to 30 days
次要结局
- Changes from baseline in vital signs (blood pressure and heart rate)(up to 30 days)
- Tolerability of the trial medications by the subject(up to 30 days)
- Incidence of all adverse events(up to 30 days)
- Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)(up to 44 days)
- Overall tolerability assessed by the subject and the investigator on a four-point rating scale(day 30)
- Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale(day 30)
研究者
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