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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteer
• Intervention / Treatment: Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: CKD-501 : Lobeglitazone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-24 hrs

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (ESTIMATE): May 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 9, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Pharmacokinetic; Placebo; Metabolite; Glimepiride; Healthy male volunteer; CKD-501
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Glimepiride
• Other Study ID Numbers: CKD-19HPS10A