ACTRN12620001187932已完成1 期
An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Dapagliflozin 70 mg Extended Release Capsules in Healthy Volunteers
ovotech (Australia) Pty Limited0 个研究点目标入组 10 人开始时间: 2020年11月10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
- 10
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
- •To be eligible to participate in the study, individuals must meet all the following inclusion criteria at Screening (and at other timepoints, where specified):
- •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 equal or greater18.5 kg/m2 and smaller than35 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
- •To be eligible to participate in the study, individuals must meet NONE of the following exclusion criteria at Screening (and at other timepoints, where specified):
- •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.)
- •e. History of dysphagia or aspiration in the last 5 years.
- •f. History of an esophageal motility disorder or undergoing treatment for a gastric motility disorder.
- •g. Multiple episodes of abdominal pain, chronic constipation, or diarrhea in the prior 3 months.
- •h. Moderate or severe dysmenorrhea or menorrhagia (with use of pain medication) in the prior 3 months.
- •i. History of moderate to severe acid reflux disease or a score of equal and greater than 2 on the Acid Reflux Severity Scale (ARSS), indicating moderate to severe symptoms. The ARSS scale is as follows:
- •None = 0 no symptoms.
- •Mild = 1 awareness of symptom, but easily tolerated.
- •Moderate = 2 discomfort sufficient to cause interference with normal activities.
- •Severe = 3 incapacitating, with inability to perform normal activities.
- •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.
- •d. Known immunocompromised status, including individuals who have undergone organ transplantation, are on immunosuppression therapy for an immune mediated disease, or are positive for HIV.
- •e. Positive test for active hepatitis B or C at Screening. Individuals with successfully treated hepatitis B infection which has been resolved for greater than 1 year or successfully treated hepatitis C infection will not be excluded.
- •f. Donated more than 250 mL of blood within 4 weeks of Screening.
- •g. Difficulties with venipuncture/cannulation, including difficulty accessing veins for blood sampling and/or history of coagulopathy or endocarditis.
- •h. Active SARS-CoV-2 infection, as defined in the SARS-CoV-2 risk management plan.
- •i. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year).
- •j. Individuals who are contraindicated to taking dapagliflozin (FORXIGA®, FARXIGA®), e.g., severe renal impairment, end-stage renal disease, or patients on dialysis.
- •4. Use of the following medications/treatments in the 2 weeks before enrollment, including:
- •a. Proton pump in
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