The Effect of Food on the Pharmacokinetic Characteristics of CKD-501

NCT ID: NCT01071720

Last Updated: 2010-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-08-31

Brief Summary

The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.

And, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.

Detailed Description

Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.

Every time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.

Conditions

Healthy

Keywords

Healthy subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

CKD-501 1mg (fed-fasted group)

CKD-501 1mg should be administered following a high-fat, high-caloric diet(fed condition) in one period and on an empty stomach(fasting condition) in the other period.

Group Type: OTHER

CKD-501 1mg

Intervention Type: DRUG

This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.

CKD-501 1mg (fasted-fed group)

CKD-501 1mg should be administered on an empty stomach(fasting condition) in one period and following a high-fat, high-caloric diet(fed condition) in the other period.

Group Type: OTHER

CKD-501 1mg

Intervention Type: DRUG

This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.

Interventions

CKD-501 1mg

This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Between 20 aged and 45 aged in healthy adults
• Weight more than 45kg, IBW 20% within the range
• 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) with affect the ADME of drug
• Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine 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(SGOT) or ALT(SGPT) > 1.25 x upper limit of normal range
• Total bilirubin > 1.5 x upper limit of normal range
• Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)
• Subject with known for hypersensitivity reactions to glitazone
• Previously participated in other trial within 60 days
• Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
• Subject takes an abnormal meal which affect the ADME of drug
• Not able to taking the institutional standard meal
• Previously make whole blood donation within 60 days or component blood donation within 20 days
• Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette > 10 cigarettes per day)
• An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
• Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chong Kun Dang Pharmaceutical

Principal Investigators

Ji Young Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Other Identifiers

CKD-19HPS09L

Identifier Type: -

Identifier Source: org_study_id