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

yndra Australia Pty Ltd0 sites44 target enrollmentNovember 15, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 15, 2019

End Date

April 21, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

yndra Australia Pty Ltd

•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;