Hepatitis B
Conditions
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.
Interventions
DRUGVemlidy Tab
1T
DRUGDA-2803 Tab
1T
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed