The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

Phase 1

Completed

• Conditions: Healthy Male Volunteer
• Interventions: Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet; Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet

• Registration Number: NCT01133431
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride	CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet	This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride	CKD-501 placebo tablet, Glimepiride 4 mg tablet	This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride	CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet	This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.
CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride	CKD-501 placebo tablet, Glimepiride 4 mg tablet	This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Primary Outcome Measures

Name	Time	Method
To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects	0-24 hrs	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

Name	Time	Method
To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501	0-24 hrs	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

Trial Locations

Locations (1)

The Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of