Drug Interaction Between CKD-501 and Metformin (CKD-19HPS09H)

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: Metformin; Drug: CKD-501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005160

CKD-19HPS09H

19HPS09H

Details and patient eligibility

About

The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.

Full description

Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.

In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.

Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.

Enrollment: 24 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between 20 aged and 45 aged in healthy males
• Weight more than 55kg, IBW 20% within the range
• FPG 70~125 mg/dL
• Agreement with written informed consent

Exclusion criteria

• Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
• Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
• Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
• AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
• systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
• Substance abuse, or a history of drug abuse showed a positive for the party
• Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
• Previously participated in other trial within 2 months
• Medication within 2 months make whole blood donation or medication within 1 month in component blood donation
• Continued to be drunk or during clinical trials can not be drunk
• 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke
• Containing grapefruit foods ingested during clinical trials or can not be ingested
• Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested

Trial design

24 participants in 1 patient group

CKD501

Experimental group

Treatment:

Drug: CKD-501

Drug: Metformin