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HealthyPhase 1NCT04671316

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

A Phase 1 study testing DA-5209 60mg Tab and Lixiana 60mg Tab in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DA-5209 60mg Tab and Lixiana 60mg Tab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteSouth Korea
Study dates
23 Nov 2020to 4 Feb 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • H Plus Yangji Hospital

    Seoul, 08779

Other trials in South Korea

About this study

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

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

Read the 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
Conditions
Healthy
Being tested
DA-5209 60mg Tab, Lixiana 60mg Tab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DA-5209 60mg TabDrug

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

  • DA-5209 60mg TabDrug

    single oral administration of 1 tablet of "DA-5209 60mg Tab" without water

  • Lixiana 60mg TabDrug

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

Study groups in NCT04671316
Study groupRoleWhat they receive
T1T2RExperimentalPeriod I: T1, "DA-5209 60mg" without water Period II: T2, "DA-5209 60mg" with 150mL water Period III: R, "Lixiana 60mg" with 150mL water
Receives: Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab
T1RT2ExperimentalPeriod I: T1, "DA-5209 60mg" without water Period II: R, "Lixiana 60mg" with 150mL water Period III: T2, "DA-5209 60mg" with 150mL water
Receives: Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab
RT1T2ExperimentalPeriod I: R, "Lixiana 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: T2, "DA-5209 60mg" with 150mL water
Receives: Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab
RT2T1ExperimentalPeriod I: R, "Lixiana 60mg" with 150mL water Period II: T2, "DA-5209 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water
Receives: Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab
T2RT1ExperimentalPeriod I: T2, "DA-5209 60mg" with 150mL water Period II: R, "Lixiana 60mg" with 150mL water Period III: T1, "DA-5209 60mg" without water
Receives: Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab
T2T1RExperimentalPeriod I: T2, "DA-5209 60mg" with 150mL water Period II: T1, "DA-5209 60mg" without water Period III: R, "Lixiana 60mg" with 150mL water
Receives: Drug: DA-5209 60mg Tab; Drug: Lixiana 60mg Tab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban

    Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban

    Measured: Before administration ~ 48hours

  2. Peak Plasma Concentration(Cmax) of Edoxaban

    Peak Plasma Concentration(Cmax) of Edoxaban

    Measured: Before administration ~ 48hours

Secondary outcomes (6)

  1. Absorption rate constant(Ka) of Edoxaban

    Absorption rate constant(Ka) of Edoxaban

    Measured: Before administration ~ 48hours

  2. % of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban

    % of concentration compared to Maximum observed plasma concentration(Cmax) of Edoxaban

    Measured: Before administration ~ 48hours

  3. 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

    Measured: Before administration ~ 48hours

  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

    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

    Measured: Before administration ~ 48hours

  5. Time of peak concentration(Tmax) of Edoxaban

    Time of peak concentration(Tmax) of Edoxaban

    Measured: Before administration ~ 48hours

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

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

    Measured: Before administration ~ 48hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start23 Nov 2020
  3. Primary completion4 Feb 2021
  4. Study completion4 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Crossover Assignment single-dose, 6-sequence, 3-period Bioequivalence Study
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671316
Sponsor's protocol ID
DDS20-035BE
Status last verified
Feb 2021
First submitted
23 Nov 2020
Last updated
9 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DA-5209 60mg Tab and Lixiana 60mg Tab in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the plasma Concetration versus time curve(AUCt) of Edoxaban (time frame: Before administration ~ 48hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04671316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.

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Clinical Trial NCT04671316 | AzTrials