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

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04671316
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Arms: 6
• Actual Duration (Months): 2.4
• Patients Per Site Per Month: 50.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DA-5209 60mg Tab; Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab	Phase 1

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.

1. Wash out period: at least 7 days

2. 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)

3. Analysis: Measurement of the concentration of an unchangeable substance of Edoxaban in plasma

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover Assignment single-dose, 6-sequence, 3-period Bioequivalence StudyCrossover Assignment single-dose, 6-sequence, 3-period Bioequivalence Study
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Nov 23, 2020
• Actual Primary Completion Date: Feb 4, 2021
• Actual Study Completion Date: Feb 4, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Peak Plasma Concentration(Cmax) of Edoxaban [Before administration ~ 48hours]

   Peak Plasma Concentration(Cmax) of Edoxaban

Secondary Outcome Measures

1. Absorption rate constant(Ka) of Edoxaban [Before administration ~ 48hours]

   Absorption rate constant(Ka) of Edoxaban

2. % 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

3. 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

4. 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

5. Time of peak concentration(Tmax) of Edoxaban [Before administration ~ 48hours]

   Time of peak concentration(Tmax) of Edoxaban

6. Terminal phase of Half-life(t1/2) of Edoxaban [Before administration ~ 48hours]

   Terminal phase of Half-life(t1/2) of Edoxaban

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. No congenital or chronic diseases or pathological symptoms

2. A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination

3. 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

4. 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)

1. 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

2. A person who has medical history of mental disease

3. A person who is judged not to be suitable for the study by the investigator

4. Lactating or possibly pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus Yangji Hospital	Seoul		Korea, Republic of	08779

Sponsors and Collaborators

• Dong-A ST Co., Ltd.

Investigators

• Principal Investigator: SeungHyun Kang, Ph.D, H Plus Yangji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04671316
• Other Study ID Numbers: DDS20-035BE
• First Posted: Dec 17, 2020
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 9, 2021