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

Dong-A ST

Status and phase

Completed

Phase 1

Conditions

Hepatitis B

Treatments

Drug: Vemlidy Tab

Drug: DA-2803 Tab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04906109

DA2803_BE_I

Details and patient eligibility

About

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects

Full 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.

Enrollment

96 patients

Sex

All

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.