Clinical trial NCT01005160: Drug Interaction Between CKD-501 and Metformin
Official title: A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Mellitus, type 2
pharmacokinetic evaluation
drug interaction between CKD-501 and metformin
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-10-30
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: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: CKD - 501 and metformin Pharmacokinetics evaluation
timeFrame: 16 days
Secondary outcomes:
measure: CKD-501 and metformin safety evaluation
timeFrame: 16 days
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung S Yu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin D, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects. Curr Med Res Opin. 2012 Jul;28(7):1213-20. doi: 10.1185/03007995.2012.703131. Epub 2012 Jul 2.