Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671316
• Other study ID #: DDS20-035BE
• Status: Completed
• Phase: Phase 1
• Start date: November 23, 2020
• Est. completion date: February 4, 2021

Study information

• Verified date: February 2021
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DA-5209 60mg Tab
single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water
• DA-5209 60mg Tab
single oral administration of 1 tablet of "DA-5209 60mg Tab" without water
• Lixiana 60mg Tab
single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Peak Plasma Concentration(Cmax) of Edoxaban	Peak Plasma Concentration(Cmax) of Edoxaban	Before administration ~ 48hours
Secondary	Absorption rate constant(Ka) of Edoxaban	Absorption rate constant(Ka) of Edoxaban	Before administration ~ 48hours
Secondary	% of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban	% of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban	Before administration ~ 48hours
Secondary	Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8) of Edoxban	Area under the plasma drug concentration-time curve from time 0 to infinity(AUC8) of Edoxban	Before administration ~ 48hours
Secondary	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC8) of Edoxaban	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity(AUCt/AUC8) of Edoxaban	Before administration ~ 48hours
Secondary	Time of peak concentration(Tmax) of Edoxaban	Time of peak concentration(Tmax) of Edoxaban	Before administration ~ 48hours
Secondary	Terminal phase of Half-life(t1/2) of Edoxaban	Terminal phase of Half-life(t1/2) of Edoxaban	Before administration ~ 48hours