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Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg

NCT03601910 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-07-26

No results posted yet for this study

Summary

This study is an open-label, randomized, fasted, single-dose, 2-way crossover study to compare the pharmacokinetic characteristics and safety between CKD-380 10mg and D308 10mg in healthy male adults.

Conditions

  • Type II Diabetes Mellitus

Interventions

DRUG

D308 10mg Tab.

D308 10mg Tab.1T single oral administration under fasting condition

DRUG

CKD-380 10mg Tab.

CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Seunghoon Han, Professor · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2018-09-21
Completion
2018-11-09

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 NCT03601910 on ClinicalTrials.gov