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
  Purpose

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


Condition Intervention Phase
Healthy Male Volunteer
Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet
Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01133431

Locations
Korea, Republic of
The Korea University Anam Hospital
Seoul, Korea, Republic of
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: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01133431     History of Changes
Other Study ID Numbers: CKD-19HPS10A
Study First Received: May 27, 2010
Last Updated: December 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-501
Glimepiride
Placebo
Healthy male volunteer
Pharmacokinetic
Metabolite

Additional relevant MeSH terms:
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 01, 2014