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CompletedNCT01133431CKD-501 DDIUpdated Dec 10, 2010

The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

A Phase 1 interventional study of CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet and CKD-501 placebo tablet, Glimepiride 4 mg tablet in Healthy Male Volunteer, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-10.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy Male Volunteer

Keywords

  • CKD-501
  • Glimepiride
  • Placebo
  • Healthy male volunteer
  • Pharmacokinetic
  • Metabolite
03

In context

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • 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 · 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.

    Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet · Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet

Interventions

  • DrugCKD-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.

    Also known as: CKD-501 : Lobeglitazone

  • DrugCKD-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.

    Also known as: CKD-501 : Lobeglitazone

06

What researchers measure

Primary outcomes

  1. To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects

    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

    Time frame: 0-24 hrs

Secondary outcomes

  1. To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501

    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

    Time frame: 0-24 hrs

07

Study locations

1 site
  • The Korea University Anam Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01133431
Lead sponsor
Chong Kun Dang Pharmaceutical
First posted
May 28, 2010
Start date
May 2010
Primary completion
Jun 2010
Completion
Aug 2010
Last update
Dec 10, 2010

Study contacts

Ji Young Park, Ph.D.
principal investigator · Korea University Anam Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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