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

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01071720
First received: February 18, 2010
Last updated: December 9, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: CKD-501 1mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting) [ Time Frame: 0-48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on [ Time Frame: Throughout the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
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.
Drug: 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.

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071720

Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Ji Young Park, Ph.D. Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Soo-Yeon Kim/CRA, Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01071720     History of Changes
Other Study ID Numbers: CKD-19HPS09L
Study First Received: February 18, 2010
Last Updated: December 9, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
Healthy subjects

ClinicalTrials.gov processed this record on April 20, 2014