Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 Tablet, in Healthy Volunteers

Chong Kun Dang Pharmaceutical1 site in 1 country28 target enrollmentJuly 2009

ConditionsHealthy

InterventionsCKD-4101 tablet Mycophenolate Mofetil capsule

DrugsCKD-4101 tablet Mycophenolate Mofetil capsule

Overview

Phase: Phase 1
Intervention: CKD-4101 tablet
Conditions: Healthy
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 28
Locations: 1
Primary Endpoint: To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Healthy volunteers are administrated single-dose over the period I and II (Crossover) of CKD-4101 1000mg and Mycophenolate mofetil capsule 1000mg. Every time before and after each medication, PK parameters and safety of CKD-4101 tablet and Mycophenolate mofetil capsule is performed using a blood sample and conducting some tests respectively.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

October 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Eligibility Criteria

Inclusion Criteria

•Between 20 aged and 45 aged in healthy males
•Weight more than 45 kg, IBW ± 20% within the range
•Ideal body weight = (Height cm - 100) x 0.9
•Agreement with written informed consent

Exclusion Criteria

•Subject has symptoms of acute disease within 28 days of starting administration of investigational drug
•Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) which affect the ADME of drug
•Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, Blood system, digestive system, central nervous system, mental disease or malignancy disease.
•Inadequate subject by medical examination(medical history, physical examination,ECG, laboratory test) within 28 days of starting administration of investigational drug
•Inadequate result of laboratory test
•AST or ALT \> 1.25 x upper limit of normal range
•Total bilirubin \> 1.25 x upper limit of normal range
•Abnormal level of WBC, Platelet, Hemoglobin WBC \< 3.5 x 1000/µL PLT \< 100 x 1000/µL Hemoglobin \< 11g/dL
•Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
•HGPRT(Hypoxanthine-guanine phosphoribosyl-transferase)deficiency patient such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome

Arms & Interventions

CKD-4101 tablet

Intervention: CKD-4101 tablet

Mycophenolate Mofetil capsule

Intervention: Mycophenolate Mofetil capsule

Outcomes

Primary Outcomes

To evaluate the pharmacokinetics of CKD-4101 tablet and Mycophenolate Mofetil capsule.

Time Frame: 0-48 hrs

Secondary Outcomes

To evaluate the safety of CKD-4101 tablet and Mycophenolate Mofetil capsule from vital signs, physical exam, ECG, laboratory test, adverse event and so on.(0-48 hrs)