Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects
- Registration Number
- NCT04473417
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A, Sequence I Forxiga Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga® Part A, Sequence I DA-2811 Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga® Part A, Sequence II Forxiga Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811 Part A, Sequence II DA-2811 Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811 Part B, Sequence I DA-2811 Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state Part B, Sequence II DA-2811 Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state
- Primary Outcome Measures
Name Time Method Cmax pre-dose~48 hours post-dose Maximum plasma concentration
AUClast pre-dose~48 hours post-dose Area under the plasma concentration-time curve from time zero to time the last quantifiable time
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Bundangseoul national unversity hospital
🇰🇷Sŏngnam, GyeonggiDo, Korea, Republic of