Status:
COMPLETED
Bioequivalence Study Between "DA-5209 Tab" and "Lixiana Tab"
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 ...
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 h...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04671316
Start Date
November 23 2020
End Date
February 4 2021
Last Update
February 9 2021
Active Locations (1)
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1
H Plus Yangji Hospital
Seoul, South Korea, 08779