Text Size

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
History of Changes
  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:

MedlinePlus related topics: Drug Reactions
Drug Information available for: Glimepiride
U.S. FDA Resources

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
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013