Status:
COMPLETED
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers. The study will also compare the pharmacokinetics and safe...
Eligibility Criteria
Inclusion
- Healthy male and/or female subjects
- BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
- Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress.
Exclusion
- Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
- Vulnerable to dehydration due to poor oral intake or clinically significant dehydration as judged by the investigator
- History of gastrointestinal disease or any gastrointestinal surgery(except for simple appendectomy, hernia surgery, hemorrhoid surgery)
- History of diseases that may impact absorption, distribution, metabolism, and excretion of the study drugs.
- Hypersensitivity to a drug containing an ingredient of the investigational product, Sodium glucose transporter-2 inhibitors, additional ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
- History of clinically significant active chronic disease
- volunteer who has genetic disorder like lapp lactase deficiency or glucose-galactose malabsorption.
- History of clinically significant allergies including drug allergies
- History of drug abuse or addicted
- Clinical laboratory test values are outside the accepted normal range
- Participation in another clinical trial within 6 months of the first IP administration
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by dual contraceptive method until 2 months after last IP administration
- Breast-feeding period, pregnant, or positive to urine pregnancy test (conducted before the first drug administration)
- Subjects considered as unsuitable based on medical judgement by investigators
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04473417
Start Date
August 4 2020
End Date
October 12 2020
Last Update
March 5 2021
Active Locations (1)
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1
Bundangseoul national unversity hospital
Sŏngnam, GyeonggiDo, South Korea