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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteer

Treatments: Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet; Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133431

CKD-19HPS10A

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

CKD-501 + Glimepiride -> CKD-501 placebo + Glimepiride

Experimental group

Description:

This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Treatment:

Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet

Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet

CKD-501 placebo + Glimepiride -> CKD-501 + Glimepiride

Experimental group

Description:

This study is randomized, single-blinded, two-period, 2 treatments, crossover design to assess the pharmacokinetics interaction between CKD-501 and sulfonylurea.

Treatment:

Drug: CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet

Drug: CKD-501 placebo tablet, Glimepiride 4 mg tablet