Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
- Registration Number
- NCT04906109
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
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Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
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Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2
- BMI = Weight(kg)/ Height(m)2
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Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
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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
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History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
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Any medical history that may affect drug absorption, distribution, metabolism and excretion.
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Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
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Any clinically significant chronic medical illness.
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Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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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.
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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.
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Individuals who cannot eat standard meal provided from clinical trial center.
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Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
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Individuals who had received a blood transfusion within 60 days prior to study drug administration.
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Exposure to any investigational drug within 6 months prior to the first IP administration.
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Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
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Individuals who had drinking (alcohol > 21unit/week) within 14 days prior to screening.
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Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
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Subjects having been deemed inappropriate for the trial as determined by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test-Reference DA-2803 Tab - Reference-Test Vemlidy Tab - Reference-Test DA-2803 Tab - Test-Reference Vemlidy Tab -
- Primary Outcome Measures
Name Time Method AUCt of DA-2803, Vemlidy pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final
Cmax of DA-2803, Vemlidy pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour The maximum DA-2803/Vemlidy concentration in blood sampling time t
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of