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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014