Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"
- Registration Number
- NCT04671316
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
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
- Detailed Description
1. Study design: An open-Label, randomized, 6-sequence, 3-period, fasting condition, single-dose, per oral, cross-over study
2. 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.
3. Wash out period: at least 7 days
4. 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)
5. Analysis: Measurement of the concentration of an unchangeable substance of Edoxaban in plasma
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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A person who aged 19 or older at the time of screening
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BMI of 18 to 30 (BMI calculation: kg/m2)
◦Males or Females weighing 60kg or more
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No congenital or chronic diseases or pathological symptoms
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A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
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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
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A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP
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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
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A person who has participated in other clinical trials within six months prior to the first administration of the IP
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A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
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A person who has medical history of gastric resection that can affect the drug absorption
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A person with a history of regular alcohol intake within a month prior to the first administration of the IP:
- Male: More than 21 cups/week
- Female: More than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits)
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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
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A person who has medical history of mental disease
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A person who is judged not to be suitable for the study by the investigator
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Lactating or possibly pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description RT1T2 Lixiana 60mg Tab 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 Lixiana 60mg Tab 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 Lixiana 60mg Tab 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 T1RT2 DA-5209 60mg Tab 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 T1RT2 Lixiana 60mg Tab 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 T1T2R Lixiana 60mg Tab 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 T1T2R DA-5209 60mg Tab 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 RT1T2 DA-5209 60mg Tab 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 DA-5209 60mg Tab 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 DA-5209 60mg Tab 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 T2T1R DA-5209 60mg Tab 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 T2T1R Lixiana 60mg Tab 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
- Primary Outcome Measures
Name Time Method Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban Before administration ~ 48hours Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban
Peak Plasma Concentration(Cmax) of Edoxaban Before administration ~ 48hours Peak Plasma Concentration(Cmax) of Edoxaban
- Secondary Outcome Measures
Name Time Method 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 from time 0 to infinity(AUC∞) of Edoxban
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 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
% of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban Before administration ~ 48hours % of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban
Time of peak concentration(Tmax) of Edoxaban Before administration ~ 48hours Time of peak concentration(Tmax) of Edoxaban
Terminal phase of Half-life(t1/2) of Edoxaban Before administration ~ 48hours Terminal phase of Half-life(t1/2) of Edoxaban
Absorption rate constant(Ka) of Edoxaban Before administration ~ 48hours Absorption rate constant(Ka) of Edoxaban
Trial Locations
- Locations (1)
H Plus Yangji Hospital
🇰🇷Seoul, Korea, Republic of