Healthy
Conditions
Keywords
Healthy subjects
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.
Interventions
DRUGCKD-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.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting) | 0-48 hrs |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on | Throughout the trial |
Outcome results
None listed