An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Dapagliflozin Extended Release Capsules in Healthy Volunteers.

yndra Australia Pty Ltd0 个研究点目标入组 44 人开始时间: 2019年11月15日最近更新: 2022年3月14日

试验速览

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•1.Provision of signed and dated informed consent;
•2.Stated willingness to comply with all protocol-specified procedures and availability for the duration of the study;
•3.Good current health, in the opinion of the Investigator, as evidenced on review of medical history, no significant gastrointestinal abnormalities, physical examination, concomitant medications, and other safety assessments;
•4.Body mass index (BMI) of greater than or equal to 18 kg/m2 and less than or equal to 30 kg/m2;
•5.Body weight greater than or equal to 55 kg.

•1.Any known clinically significant esophageal or gastrointestinal disease;
•2.Unusual score for swallowing questionnaire.
•3.Do not demonstrate normal swallowing and gastrointestinal passage for capsule, as assessed while undergoing imaging studies.
•4.Symptoms suggestive of irritable bowel syndrome, functional constipation or functional diarrhea;
•5.History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
•6.Clinically significant abnormal safety (e.g., physical examination) or safety laboratory assessments;
•7.Hepatitis B, hepatitis C, or H. pylori infection at Screening, unless there is a confirmed medical history of successful treatment;
•8.Use of prescription medications, natural remedies, vitamins or non-prescription medicines associated with changes to gastric motility or pH or management of gastrointestinal symptoms within two weeks of study dosing;
•9.Individuals who are contraindicated based on dapagliflozin;
•10.History of any drug or alcohol use disorder in the past 2 years;
•11.Individuals of reproductive potential who are (hetero) sexually active but unwilling to use acceptable means of contraception through the End of Study;
•12.Individuals who are nursing or who have positive or indeterminate pregnancy tests at screening.

发起方

yndra Australia Pty Ltd