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An Open-Label, Randomized, 6-sequence, 3-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "DA-5209 60mg Tab" and "Lixiana 60mg Tab" in Healthy Volunteers
Study design: An open-Label, randomized, 6-sequence, 3-period, fasting condition, single-dose, per oral, cross-over study
Administration method:
The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (DA-5209 60mg) without water or (DA-5209 60mg or Lixiana 60mg) with 150 mL of water at around 8 a.m. on the day of the test. The subject should not chew or break the drug, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the blood collection time.
Wash out period: at least 7 days
Blood collection time: Before the administration, 5, 10, 15, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hr after the administration (total 15 times)
Analysis: Measurement of the concentration of an unchangeable substance of Edoxaban in plasma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1T2R | Experimental | Period I: T1, "DA-5209 60mg" without water Period II: T2, "DA-5209 60mg" with 150mL water Period III: R, "Lixiana 60mg" with 150mL water |
|
| T1RT2 | Experimental | Period I: T1, "DA-5209 60mg" without water Period II: R, "Lixiana 60mg" with 150mL water Period III: T2, "DA-5209 60mg" with 150mL water |
|
| RT1T2 | Experimental | Period I: R, "Lixiana 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: T2, "DA-5209 60mg" with 150mL water |
|
| RT2T1 | Experimental | Period I: R, "Lixiana 60mg" with 150mL water Period II: T2, "DA-5209 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water |
|
| T2RT1 | Experimental | Period I: T2, "DA-5209 60mg" with 150mL water Period II: R, "Lixiana 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-5209 60mg Tab | Drug | single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban | Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban | Before administration ~ 48hours |
| Peak Plasma Concentration(Cmax) of Edoxaban | Peak Plasma Concentration(Cmax) of Edoxaban | Before administration ~ 48hours |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption rate constant(Ka) of Edoxaban | Absorption rate constant(Ka) of Edoxaban | Before administration ~ 48hours |
| % of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban |
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Inclusion Criteria:
A person who aged 19 or older at the time of screening
BMI of 18 to 30 (BMI calculation: kg/m2)
◦Males or Females weighing 60kg or more
No congenital or chronic diseases or pathological symptoms
A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
Exclusion Criteria:
A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of IP
A person who has participated in other clinical trials within six months prior to the first administration of the IP
A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
A person who has medical history of gastric resection that can affect the drug absorption
A person with a history of regular alcohol intake within a month prior to the first administration of the IP:
A person who is hypersensitive to any of the IP components, with clinically significant bleeding, with end-stage renal disease and have kidney dialysis, with hepatic disease related to blood coagulation disorder and clinically significant risk of bleeding, with severe liver impairment, with an increased risk of bleeding, use combination therapy with other anticoagulants, Severe hypertension factor, have undergone artificial heart valve replacement
A person who has medical history of mental disease
A person who is judged not to be suitable for the study by the investigator
Lactating or possibly pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| SeungHyun Kang, Ph.D | H Plus Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | 08779 | South Korea |
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Crossover Assignment single-dose, 6-sequence, 3-period Bioequivalence Study
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|
| T2T1R | Experimental | Period I: T2, "DA-5209 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: R, "Lixiana 60mg" with 150mL water |
|
| DA-5209 60mg Tab | Drug | single oral administration of 1 tablet of "DA-5209 60mg Tab" without water |
|
| Lixiana 60mg Tab | Drug | single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water |
|
% of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban
| Before administration ~ 48hours |
| Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) of Edoxban | Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) of Edoxban | Before administration ~ 48hours |
| Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC∞) of Edoxaban | Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC∞) of Edoxaban | Before administration ~ 48hours |
| Time of peak concentration(Tmax) of Edoxaban | Time of peak concentration(Tmax) of Edoxaban | Before administration ~ 48hours |
| Terminal phase of Half-life(t1/2) of Edoxaban | Terminal phase of Half-life(t1/2) of Edoxaban | Before administration ~ 48hours |