ACTRN12618001929291已完成1 期
A Phase I, Proof-of-Concept, Randomised, Double-Blind, Cross-Over Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetic Profile of LipoCeramic™ Simvastatin.
Reform Pharm Pty Ltd0 个研究点目标入组 12 人开始时间: 2018年11月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Gender: Male.
- •2. Age: 18 years and over.
- •3. General Health: Healthy. Health status will be determined by the subject’s medical history with specific attention to: (I) drug history identifying any known drug allergies or drug abuse, (II) any chronic use of medication, and (III) a thorough review of body systems. This will also be determined after a physical examination, including an electrocardiogram (ECG), revealing no abnormal findings, which in the opinion of the Principal Investigator, or medical nominee, would risk the safety of the subject of impact the validity of the study results.
- •4. Venous Access: Subjects require adequate venous access on their left or right arm to allow for collection of numerous blood samples.
- •5. Language: Fluent in English.
- •6. Informed Consent: Subject must voluntarily give written informed consent to participate in this study.
排除标准
- •1. Hypersensitivity: History of hypersensitivity and/or allergy to simvastatin or any of the ingredients which are listed in the formulation, including soy. Hypersensitivity to lignocaine/lidocaine or any surgical dressings which may be used during the study.
- •2. Medical Conditions: (a) History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders. (b) Any pre-existing condition which may interfere with the absorption, distribution, metabolism and/or excretion of drugs. (c) History of abnormal bleeding tendencies or thrombophlebitis unrelated to venous puncture or intravenous cannulation, or a history of Hepatitis B or C, or a positive test for Hepatitis antigen or antibodies, a history of HIV infection or presence of HIV antibodies.
- •3. Abnormal Laboratory Results: Any evidence of organ dysfunction or abnormality in clinical laboratory results which is deemed significant which would risk the safety of the subject of impact the validity of the study results.
- •4. Ethanol Use: Regular drinkers who consume more than four units of alcohol daily or those who may have difficulty abstaining from alcohol for 24 hours prior to dose administration and 8.5 hours following dose administration.
- •5. Drug and Alcohol Abuse: History or current evidence of alcohol or drug abuse, licit or illicit, or positive urine drug and breath alcohol screen.
- •6. Medication: Difficulty in refraining from the administration of potent CYP3A4 inhibitors for 14 days prior to the initial dose administration and until the exit evaluation. Subjects will be instructed not to take any prescription medication for 14 days prior to the first dose administration and for the duration of the study and to abstain from over- the-counter (OTC) medication within 7 days prior to initial dose administration and until the Exit Evaluation.
- •7. Xanthine Use: Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthines (I.e. coffee, tea, cola and chocolate) during 24 hours prior to dose administration until the completion of blood sampling in each study period.
- •8. Psychiatric or Psychological Disorder: History or presence of any psychiatric ill ness or psychological disorder which may impair the subject’s ability to provide written consent or participate in the study.
- •9. Blood Donation: Standard blood donation (usually 550 mL) within the 12-week period before dose administration until the exit evaluation.
- •10. Dietary Habits: Unusual dietary habits including vegetarian diets, excessive or unusual vitamin intake. Difficulty in abstaining from grapefruit juice for 24 hours prior to dose administration until the exit evaluation.
- •11. Food Consumption: Difficulty in refraining from food consumption from 2300 hours the night before dosing (I.e. for 10 hours prior to dosing).
- •12. Tobacco: Tobacco users who smoke more than 10 cigarettes (or equivalent) per day and/or who are unable to refrain from smoking whilst confined in the Clinical Trial Facility each study period.
- •13. Contraception: Unwilling to use adequate contraception for the duration of the study (e.g. condoms), unless surgically sterile
- •14. Recent Study Participation: Consumption of any drug as part of a research study within 30 days of the initial dose administration in this study.
- •15. Protocol Compliance: Poor
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