The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

Healthy Male Volunteer Clinical Trial

— CKD-501 DDI  

Official title:

Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133431
• Other study ID #: CKD-19HPS10A
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2010
• Last updated: December 9, 2010
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2010
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Male Volunteer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	The Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No