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Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet

NCT01016626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-11-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic characteristics between the CKD-4101 tablet and Mycophenolate mofetil capsule when administered alone to healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

CKD-4101 tablet

CKD-4101 tablet 1000 mg * 500mg/tablet, PO, 2 tablet once daily for D1 and D8(crossover)

DRUG

Mycophenolate Mofetil capsule

Mycophenolate Mofetil capsule 1000 mg * 250mg/capsule, PO, 4 capsule once daily for D1 and D8(crossover)

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-08-31
Completion
2009-10-31

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 NCT01016626 on ClinicalTrials.gov