Clinical trial NCT01071720: The Effect of Food on the Pharmacokinetic Characteristics of CKD-501
Official title: Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)
timeFrame: 0-48 hrs
Secondary outcomes:
measure: To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on
timeFrame: Throughout the trial
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Anam Hospital
name: Ji Young Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: