Status:
COMPLETED
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Hepatitis B
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects
Detailed Description
To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab....
Eligibility Criteria
Inclusion
- Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2
- BMI = Weight(kg)/ Height(m)2
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
- Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial
Exclusion
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
- Any clinically significant chronic medical illness.
- Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Individuals with one of the following laboratory test results in screening.
- AST, ALT \> UNL (upper normal limit) x 1.5
- Creatinine clearance ≤ 60 mL/min
- Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
- Individuals who cannot eat standard meal provided from clinical trial center.
- Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
- Individuals who had received a blood transfusion within 60 days prior to study drug administration.
- Exposure to any investigational drug within 6 months prior to the first IP administration.
- Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- Individuals who had drinking (alcohol \> 21unit/week) within 14 days prior to screening.
- Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2021
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04906109
Start Date
July 12 2021
End Date
October 5 2021
Last Update
July 14 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505