Drug Interaction Between CKD-501 and Metformin

Overview[ - collapse ][ - ]

Purpose 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.
ConditionHealthy Male Volunteers
InterventionDrug: Metformin
Drug: CKD-501
PhasePhase 1
SponsorChong Kun Dang Pharmaceutical
Responsible PartyChong Kun Dang Pharmaceutical
ClinicalTrials.gov IdentifierNCT01005160
First ReceivedOctober 28, 2009
Last UpdatedJanuary 10, 2011
Last verifiedOctober 2009

Tracking Information[ + expand ][ + ]

First Received DateOctober 28, 2009
Last Updated DateJanuary 10, 2011
Start DateOctober 2009
Estimated Primary Completion DateFebruary 2010
Current Primary Outcome MeasuresCKD - 501 and metformin Pharmacokinetics evaluation [Time Frame: 16 days] [Designated as safety issue: No]
Current Secondary Outcome MeasuresCKD-501 and metformin safety evaluation [Time Frame: 16 days] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleDrug Interaction Between CKD-501 and Metformin
Official TitleA 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
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.
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionHealthy Male Volunteers
InterventionDrug: Metformin
CKD-501 0.5mg, metformin 1000mg
Other Names:
LobeglitazoneDrug: CKD-501
CKD-501 0.5mg, metformin 1000mg
Other Names:
Lobeglitazone
Study Arm (s)Experimental: CKD501

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment24
Estimated Completion DateFebruary 2010
Estimated Primary Completion DateDecember 2009
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
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01005160
Other Study ID NumbersCKD-19HPS09H
Has Data Monitoring CommitteeNo
Information Provided ByChong Kun Dang Pharmaceutical
Study SponsorChong Kun Dang Pharmaceutical
CollaboratorsNot Provided
Investigators Principal Investigator: Kyung S Yu Seoul National University Hospital
Verification DateOctober 2009