CTRI/2019/12/022361已完成2 期
An open label, parallel study to evaluate the steady state pharmacokinetics of Vitamin K2-7 capsules 350 mcg of Synergia Life Sciences Pvt. Ltd after multiple dose administered in normal, healthy, adult, human male subjects under fed condition
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To characterize the Steady state pharmacokinetic profile of Vitamin K2-7 capsule 350 mcg after multiple oral dose administration in normal, healthy, adult, human male subjects under fed condition.
研究概览
简要总结
An open label, parallel study to evaluate the steady state pharmacokinetics study in normal, healthy, adult, human male subjects under fed condition.
No. of subjects: 15
Vitamin K2-7 capsule of 350 mcg to be consumed everyday immediately after dinner for 21 days.
Vitamin K2-7 along with Uncarboxylated Osteocalcin (ucOC) and Carboxylated Osteocalcin (cOC) will be measured at baseline, 3rd, 7th, 14th and 21st day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Non-smokers, normal, healthy, adult, human male volunteers between 18 to 45 years of age (both inclusive).
- •Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg / height in sq.m.
- •Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view) recordings.
- •Able to understand and comply with the study procedures, in the opinion of the investigator.
- •Able to give voluntary written informed consent for participation in the study.
排除标准
- •Known hypersensitivity to Vitamin K2-7 or any excipients or any related drug or any substance.
- •2.History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •Ingestion of a medication (prescribed & over the counter (OTC) medication including herbal remedies) at any time within 14 days prior to first dosing.
- •In any such case subject selection will be at the discretion of the Principal Investigator / designee.
- •Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hours prior to check-in.
- •Smokers or who have smoked within last 06 months prior to start of the study.
- •Consumption of natto or any fermented food products such as Dosa, Ideli, Curd, Yogurt and other vitamin K containing products within 72 hours prior to check in.
- •The presence of clinically significant abnormal laboratory values during screening.
结局指标
主要结局
To characterize the Steady state pharmacokinetic profile of Vitamin K2-7 capsule 350 mcg after multiple oral dose administration in normal, healthy, adult, human male subjects under fed condition.
时间窗: 21 days
次要结局
- To monitor the safety of the subjects(22 days)
研究者
研究点 (1)
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