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

NCT04671316 | Completed Phase 1

• 1 other identifier: DDS20-035BE
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Absorption rate constant(Ka) of Edoxaban

  Before administration ~ 48hours

• % 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

  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

  Before administration ~ 48hours

• Time of peak concentration(Tmax) of Edoxaban

  Before administration ~ 48hours

Study Arms (6)

T1T2R

EXPERIMENTAL

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; Drug: Lixiana 60mg Tab

T1RT2

EXPERIMENTAL

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; Drug: Lixiana 60mg Tab

RT1T2

EXPERIMENTAL

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; Drug: Lixiana 60mg Tab

RT2T1

EXPERIMENTAL

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; Drug: Lixiana 60mg Tab

T2RT1

EXPERIMENTAL

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; Drug: Lixiana 60mg Tab

T2T1R

EXPERIMENTAL

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; Drug: Lixiana 60mg Tab

Interventions

DA-5209 60mg Tab DRUG

single oral administration of 1 tablet of "DA-5209 60mg Tab" with 150mL water

RT1T2; RT2T1; T1RT2; T1T2R; T2RT1; T2T1R

Lixiana 60mg Tab DRUG

single oral administration of 1 tablet of "Lixiana 60mg Tab" with 150mL water

RT1T2; RT2T1; T1RT2; T1T2R; T2RT1; T2T1R

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A person who aged 19 or older at the time of screening
• BMI of 18 to 30 (BMI calculation: kg/m2)
• ◦Males or Females weighing 60kg or more
• No congenital or chronic diseases or pathological symptoms
• A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
• 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
• A person who agreed to use contraception from the first administration of IP to a week after the last administration of IP

You may not qualify if:

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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

H Plus Yangji Hospital

Seoul, 08779, South Korea

Location

Study Officials

• SeungHyun Kang, Ph.D

  H Plus Yangji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Assignment single-dose, 6-sequence, 3-period Bioequivalence Study

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 17, 2020
• Study Start: November 23, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

KR (1)