Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2811 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Forxiga
* Drug: DA-2811
* Drug: DA-2811
* Drug: DA-2811


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A, Sequence I<br>Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga® | Drug: Forxiga<br>* single dose administration after 10hr fasting<br>Drug: DA-2811<br>* single dose administration after 10hr fasting<br>|
| Experimental: Part A, Sequence II<br>Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811 | Drug: Forxiga<br>* single dose administration after 10hr fasting<br>Drug: DA-2811<br>* single dose administration after 10hr fasting<br>|
| Experimental: Part B, Sequence I<br>Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state | Drug: DA-2811<br>* single dose administration after 10hr fasting<br>Drug: DA-2811<br>* single dose administration after high fat and calorie fed diet<br>|
| Experimental: Part B, Sequence II<br>Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state | Drug: DA-2811<br>* single dose administration after 10hr fasting<br>Drug: DA-2811<br>* single dose administration after high fat and calorie fed diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | Area under the plasma concentration-time curve from time zero to time the last quantifiable time | pre-dose 48 hours post-dose | 
| Cmax | Maximum plasma concentration | pre-dose 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0 - ∞) | Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - ∞) | pre-dose 48 hours post-dose | 
| Tmax | Time to reach maximum plasma concentration following drug administration | pre-dose 48 hours post-dose | 
| t1/2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | pre-dose 48 hours post dose |