Clinical trial NCT04671316: Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"
Official title: A Open-Label, Randomized, 6-sequence, 3-period, Fasting Condition, Singledose, Per Oral, Cross-over Study to Evaluate the Bioequivalence Between "DA-5209 60mg Tab" and "Lixiana 60mg Tab" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 121
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment single-dose, 6-sequence, 3-period Bioequivalence Study
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: Inclusion Criteria:

1. A person who aged 19 or older at the time of screening
2. BMI of 18 to 30 (BMI calculation: kg/m2)

   ◦Males or Females weighing 60kg or more
3. No congenital or chronic diseases or pathological symptoms
4. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
5. 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
6. A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP

Exclusion Criteria:

1. 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
2. A person who has participated in other clinical trials within six months prior to the first administration of the IP
3. A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of IP
4. A person who has medical history of gastric resection that can affect the drug absorption
5. 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)
6. 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
7. A person who has medical history of mental disease
8. A person who is judged not to be suitable for the study by the investigator
9. Lactating or possibly pregnant women

Primary outcomes:
measure: Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban
timeFrame: Before administration ~ 48hours
measure: Peak Plasma Concentration(Cmax) of Edoxaban
timeFrame: Before administration ~ 48hours
Secondary outcomes:
measure: Absorption rate constant(Ka) of Edoxaban
timeFrame: Before administration ~ 48hours
measure: % of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban
timeFrame: Before administration ~ 48hours
measure: Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) of Edoxban
timeFrame: Before administration ~ 48hours
measure: 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
timeFrame: Before administration ~ 48hours
measure: Time of peak concentration(Tmax) of Edoxaban
timeFrame: Before administration ~ 48hours
measure: Terminal phase of Half-life(t1/2) of Edoxaban
timeFrame: Before administration ~ 48hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
affiliation: H Plus Yangji Hospital
name: SeungHyun Kang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: