ACTRN12621000101886已完成1 期
An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosuvastatin Extended Release Capsules in Healthy Volunteers
yndra Therapeutics, Inc. (Lyndra)0 个研究点目标入组 16 人开始时间: 2021年2月1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
- 16
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •1. Men and women aged 18 to 64 years of age.
- •2. Individuals in good current health, in the Investigator’s opinion, as evidenced on review of medical history that includes no significant GI abnormalities, physical examination, concomitant medications, and other safety assessments.
- •3. Body mass index greater than or equal to 18.5 kg/m2 and lesser than 35 kg/m2.
- •4. Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
- •5. Willing to comply with all protocol-specified procedures and availability for the duration of the study.
排除标准
- •1. Individuals with known clinically significant esophageal or GI disease, including but not limited to:
- •a. Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or individuals with high risk of stricture, i.e., Crohn's disease.
- •b. Diagnosis of a condition known to elevate or lower gastric pH, e.g., achlorhydria or hypochlorhydria.
- •c. Prior varices or small or large bowel obstructions.
- •d. Prior abdominal or upper GI surgery. (Prior uncomplicated laparoscopic procedures are permitted.)
- •2. Individuals with PILL-5 questionnaire score of 5 or greater.
- •3. Medical history or current diagnoses indicating the presence of any of the following conditions:
- •a. Presence of an uncontrolled, unstable, clinically significant medical condition that could put the subject at risk because of participation in the study, interfere with the subject’s ability to participate in the study or influence the interpretation of safety or PK evaluations.
- •b. History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure within 6 months of Screening.
- •c. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening.
- •4. Use of the following medications/treatments in the 2 weeks before enrollment, including:
- •a. Proton pump inhibitors (PPIs).
- •b. H2 blockers.
- •c. Chronic acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs).
- •d. Prokinetic agents.
研究者
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