Healthy
Conditions
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 safety profiles of DA-2811 under fasting and fed states in healthy subjects.
Interventions
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | pre-dose~48 hours post-dose | Area under the plasma concentration-time curve from time zero to time the last quantifiable time |
| Cmax | pre-dose~48 hours post-dose | Maximum plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(0 - ∞) | pre-dose~48 hours post-dose | Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - ∞) |
| Tmax | pre-dose~48 hours post-dose | Time to reach maximum plasma concentration following drug administration |
| t1/2 | pre-dose~48 hours post dose | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
South Korea
Outcome results
None listed