KCT0000449已完成未知
An integrative pharmacogenetic-pharmacometabolomic study to predict individualized pharmacokinetics of metoprolol in healthy male subjects
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- Male
入选标准
- •1.Healthy male subjects between the ages of 20 and 50 years at screening;
- •2.Subjects with a body weight within ± 20% of their ideal weight;
- •3.Subjects must be in generally good health as determined by pre-study medical history and physical examination, with no congenital or chronic diseases;
- •4.Subjects must be able to read, understand, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
排除标准
- •1.Hypersensitivity to the study medication or any related medication, including any other constituents of the formulation or past history of allergic reaction;
- •2.Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant disease;
- •3.Diagnosis of hypotension (systolic < 105mmHg or diastolic < 65 mg) or hypertension (systolic > 150mmHg or diastolic > 100mmHg)made during the screening period or current diagnosis of hypertension
- •4.Resting pulse rate of < 50 beats per minute during the screening period.
- •5.History of alcohol abuse (>21 units/week) or subjects who are not willing to abstain from drinking for the duration of study;
- •6.A history of serious trauma within 4 weeks, or resection operation (excluding simple appendectomy or herniorrhaphy) and/or relevant history or laboratory or clinical findings indicative of acute disease
- •7.A history of drug abuse.
- •8.Use of any prescription drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to administration of study drug;
- •9.Use of any other investigational drug within 3 months prior to administration of study drug;
- •10.Donation of whole blood within 2 months or any blood products within 1 month, prior to administration of study drug;
- •11.Excessive smoking (>10 cigarettes/day)
- •12.Any abnormal diet, likely to influence absorption, distribution, metabolism, and excretion of the drug (e.g. habitually taking more than 1L of grapefruit juice/day within 7 days prior to administration of study drug)
- •13.Positive test result for hepatitis (B or C) or HIV or VDRL
- •14.Subject who is not eligible to participate in this study, as judged by an investigator.
研究者
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