Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vemlidy Tab
DA-2803 Tab
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B
Eligibility Criteria
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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Reference-Test
Test-Reference
Arm Description
Outcomes
Primary Outcome Measures
AUCt of DA-2803, Vemlidy
Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final
Cmax of DA-2803, Vemlidy
The maximum DA-2803/Vemlidy concentration in blood sampling time t
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04906109
Brief Title
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
Official Title
A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
October 5, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference-Test
Arm Type
Experimental
Arm Title
Test-Reference
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vemlidy Tab
Other Intervention Name(s)
Reference
Intervention Description
1T
Intervention Type
Drug
Intervention Name(s)
DA-2803 Tab
Other Intervention Name(s)
Test
Intervention Description
1T
Primary Outcome Measure Information:
Title
AUCt of DA-2803, Vemlidy
Description
Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final
Time Frame
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
Title
Cmax of DA-2803, Vemlidy
Description
The maximum DA-2803/Vemlidy concentration in blood sampling time t
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
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