Clinical trial NCT01133431: The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea
Official title: Clinical Study to Assess the Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea (Glimepiride) in Healthy Male Subjects: Single-blinded, Randomized, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteer
Keywords: CKD-501
Glimepiride
Placebo
Healthy male volunteer
Pharmacokinetic
Metabolite
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the Pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects
timeFrame: 0-24 hrs
Secondary outcomes:
measure: To confirm and evaluate the pharmacokinetic characters of main metabolites of CKD-501
timeFrame: 0-24 hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji Young Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: