Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects

NCT ID: NCT04906109

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2021-10-05

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference-Test

Group Type: EXPERIMENTAL

Vemlidy Tab

Intervention Type: DRUG

1T

DA-2803 Tab

Intervention Type: DRUG

1T

Test-Reference

Group Type: EXPERIMENTAL

Vemlidy Tab

Intervention Type: DRUG

1T

DA-2803 Tab

Intervention Type: DRUG

1T

Interventions

Vemlidy Tab

1T

Intervention Type: DRUG

DA-2803 Tab

1T

Intervention Type: DRUG

Other Intervention Names

Reference; Test

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

DA2803_BE_I

Identifier Type: -

Identifier Source: org_study_id