Drug Interaction Between CKD-501 and Metformin | NCT01005160

Studies
Drug Interaction Between CKD-501 and Metformin

NCT01005160

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

Jan 12, 2011Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Healthy Male Volunteers

Interventions

Metformin
CKD-501

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
19HPS09H

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Oct 29, 2009

First Posted Date

Oct 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2011

Last Update Posted Date

Jan 12, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Label	Type	Description	Intervention Names
CKD501	Experimental		Drug: Metformin Drug: CKD-501

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	CKD-501 0.5mg, metformin 1000mg	CKD501	Lobeglitazone

Measure	Description	Time Frame
CKD - 501 and metformin Pharmacokinetics evaluation		16 days

Measure	Description	Time Frame
CKD-501 and metformin safety evaluation		16 days

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kyung S Yu	Seoul National University Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22697273	Derived	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.

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

ID	Term
D008687	Metformin
C546215	lobeglitazone