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Completed

NCT Number: NCT01005160

Drug Interaction Between CKD-501 and Metformin

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.

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Key information

Conditions

Healthy Male Volunteers

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

CKD-501 0.5mg, metformin 1000mg

Other names: Lobeglitazone

CKD-501

Drug

CKD-501 0.5mg, metformin 1000mg

Other names: Lobeglitazone

Primary outcomes

  1. CKD - 501 and metformin Pharmacokinetics evaluation

    Time frame: 16 days

Secondary outcomes

  1. CKD-501 and metformin safety evaluation

    Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Acronym: CKD-19HPS09H

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 30, 2009
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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