Healthy Male Volunteer
Conditions
Keywords
CKD-501, Glimepiride, Placebo, Healthy male volunteer, Pharmacokinetic, Metabolite
Brief summary
To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.
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.
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.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed