Pure Global

Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects - Trial NCT04906109

Access comprehensive clinical trial information for NCT04906109 through Pure Global AI's free database. This Phase 1 trial is sponsored by Dong-A ST Co., Ltd. and is currently Not yet recruiting. The study focuses on Hepatitis B. Target enrollment is 96 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT04906109
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT04906109
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

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

Hepatitis B

Vemlidy Tab

Interventional

drug

Sponsor & Location

Dong-A ST Co., Ltd.

Seoul, South Korea

Timeline & Enrollment

Phase 1

Jun 10, 2021

Sep 30, 2021

96 participants

Primary Outcome

AUCt of DA-2803, Vemlidy,Cmax of DA-2803, Vemlidy

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

ICD-10 Classifications

Acute hepatitis B
Acute hepatitis B without delta-agent and without hepatic coma
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent
Chronic viral hepatitis B without delta-agent : other and unspecified phase

Data Source

ClinicalTrials.gov

NCT04906109

Non-Device Trial