The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (CKD-501 DDI)

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01133431
First received: May 27, 2010
Last updated: December 9, 2010
Last verified: May 2010

May 27, 2010
December 9, 2010
May 2010
June 2010   (final data collection date for primary outcome measure)
To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]
Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period
Same as current
Complete list of historical versions of study NCT01133431 on ClinicalTrials.gov Archive Site
To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501 [ Time Frame: 0-24 hrs ] [ Designated as safety issue: No ]
Blood sampling timepoint : Day 1(0hr), Day 4(0hr), Day 5(0hr),0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 5hr, 6hr, 8hr, 12hr, 24hr(Day 6)- total 16 timepoints per period
Same as current
Not Provided
Not Provided
 
The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea
Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study

To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Healthy Male Volunteer
  • Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
    From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.
    Other Name: CKD-501 : Lobeglitazone
  • Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet
    From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.
    Other Name: CKD-501 : Lobeglitazone
  • Experimental: CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride
    This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
    Interventions:
    • Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
    • Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet
  • Experimental: CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride
    This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
    Interventions:
    • Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
    • Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male adults aged between 20 and 45 during screening period
  • Weight more than 45kg and within ±20% range of Ideal Boby Weight
  • Agreement with written informed consent

Exclusion Criteria:

  • Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
  • Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects 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
  • Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
  • Inadequate laboratory test result

    • 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 is not needed medication)
  • Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
  • Previously participated in other trial within 60 days
  • Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
  • Subject has taken abnormal meals which affects the ADME of drug
  • Impossible to taking the institutional standard meal
  • Previously donate whole blood within 60 days or component blood within 20 days
  • Continued to be taking caffeine (caffeine > 5 cup/day), drinking(alcohol > 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette > 10 cigarettes per day)during clinical trials
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01133431
CKD-19HPS10A
No
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Not Provided
Principal Investigator: Ji Young Park, Ph.D. Korea University Anam Hospital
Chong Kun Dang Pharmaceutical
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP