Overview
Drug Interaction Between CKD-501 and Metformin
Status:
Completed
Completed
Trial end date:
2010-02-01
2010-02-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Chong Kun Dang PharmaceuticalTreatments:
Metformin
Criteria
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