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A Study to Evaluate the Relative Bioavailability of Formulations of CKD-510 and to Assess the Effect of Food on the CKD-510 Tablet Formulation in Healthy Subjects

NCT05526742 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-03-15

No results posted yet for this study

Summary

The purpose of this study is to determine the relative bioavailability of CKD-510 tablet formulation compared with CKD-510 capsule formulation, and to characterize the effect of food on the CKD-510 tablet.

Conditions

  • Healthy Volunteers

Interventions

DRUG

CKD-510 capsule (reference)

Single-dose of CKD-510 will be administered as oral capsule in a fasted state.

DRUG

CKD-510 tablet (test)

Single-dose of CKD-510 will be administered as oral tablet in a fasted state.

DRUG

CKD-510 tablet (test)

Single-dose of CKD-510 will be administered as oral tablet in a fed state.

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2022-09-13
Completion
2022-09-13
FDA Drug
Yes

Countries

  • United States

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 NCT05526742 on ClinicalTrials.gov