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

This study has been completed.
Sponsor:
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01005160
First received: October 28, 2009
Last updated: January 10, 2011
Last verified: October 2009
  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.


Condition Intervention Phase
Healthy Male Volunteers
Drug: Metformin
Drug: CKD-501
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • CKD - 501 and metformin Pharmacokinetics evaluation [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CKD-501 and metformin safety evaluation [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD501 Drug: Metformin
CKD-501 0.5mg, metformin 1000mg
Other Name: Lobeglitazone
Drug: CKD-501
CKD-501 0.5mg, metformin 1000mg
Other Name: Lobeglitazone

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005160

Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Kyung S Yu Seoul National University Hospital
  More Information

No publications provided by Chong Kun Dang Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chin Kim, Chong Kun Dang
ClinicalTrials.gov Identifier: NCT01005160     History of Changes
Other Study ID Numbers: CKD-19HPS09H, 19HPS09H
Study First Received: October 28, 2009
Last Updated: January 10, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Chong Kun Dang Pharmaceutical:
Mellitus, type 2
pharmacokinetic evaluation
drug interaction between CKD-501 and metformin

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014