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Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects

NCT04473417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-05

No results posted yet for this study

Summary

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers.

The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting and fed states in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Forxiga

single dose administration after 10hr fasting

DRUG

DA-2811

single dose administration after 10hr fasting

DRUG

DA-2811

single dose administration after 10hr fasting

DRUG

DA-2811

single dose administration after high fat and calorie fed diet

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • JaeYong Chung · Bundang Seoul National University Hospital Clinical Trial Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2020-08-26
Completion
2020-10-12

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04473417 on ClinicalTrials.gov