The Effect of Food on the Pharmacokinetic Characteristics of CKD-501 (CKD-501 FDI)

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CKD-501 1mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071720

CKD-19HPS09L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

CKD-501 1mg (fed-fasted group)

Other group

Description:

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.

Treatment:

Drug: CKD-501 1mg

CKD-501 1mg (fasted-fed group)

Other group

Description:

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.

Treatment:

Drug: CKD-501 1mg