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Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)

NCT04083846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-05

No results posted yet for this study

Summary

This study is a randomized, open-label, fed, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions.

Conditions

Interventions

DRUG

Reference drug

D744 Cap. 1 Cap., single oral administration under fed condition

DRUG

Test drug 1

CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition

DRUG

Test drug 2

CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Min-gul Kim · Chonbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2019-10-21
Completion
2019-10-25

Countries

  • South Korea

Study Locations

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Entities

Diseases

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 NCT04083846 on ClinicalTrials.gov