Status:
UNKNOWN
Bioequivalence Study Between "DA-5215 Tab" and "DA-5215-R Tab"
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers
Detailed Description
1. Study design: An open-Label, randomized, 2-sequence, 2-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 weighing 50kg or more, Females weighing 45kg 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 agreed to use contraception from the first administration of IP to a week after the last administration of IP
- 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
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 8 weeks 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
- 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 :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05376085
Start Date
May 1 2022
End Date
July 1 2022
Last Update
May 17 2022
Active Locations (1)
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1
H Plus Yangji Hospital
Seoul, South Korea, 08779