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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DA-5209 60mg Tab; Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab

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

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08779
    • H plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T1T2R; 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	Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water; Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" without water; Drug: Lixiana 60mg Tab; single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water
Experimental: T1RT2; 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	Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water; Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" without water; Drug: Lixiana 60mg Tab; single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water
Experimental: RT1T2; 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	Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water; Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" without water; Drug: Lixiana 60mg Tab; single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water
Experimental: RT2T1; 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	Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water; Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" without water; Drug: Lixiana 60mg Tab; single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water
Experimental: T2RT1; 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	Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water; Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" without water; Drug: Lixiana 60mg Tab; single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water
Experimental: T2T1R; 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	Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water; Drug: DA-5209 60mg Tab; single oral administration of 1 tablet of "DA-5209 60mg Tab" without water; Drug: Lixiana 60mg Tab; single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	% 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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: SeungHyun Kang, Ph.D, H plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): February 4, 2021

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DDS20-035BE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No