Drug Interaction Between CKD-501 and Metformin

NCT01005160 | Completed Phase 1

• 2 other identifiers: CKD-19HPS09H19HPS09H
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Male Volunteers

Keywords

Mellitus, type 2; pharmacokinetic evaluation; drug interaction between CKD-501 and metformin

Outcome Measures

Primary Outcomes (1)

• CKD - 501 and metformin Pharmacokinetics evaluation

  16 days

Secondary Outcomes (1)

• CKD-501 and metformin safety evaluation

  16 days

Study Arms (1)

CKD501

EXPERIMENTAL

Drug: Metformin; Drug: CKD-501

Interventions

Metformin DRUG

CKD-501 0.5mg, metformin 1000mg

Also known as: Lobeglitazone

CKD501

CKD-501 DRUG

CKD-501 0.5mg, metformin 1000mg

Also known as: Lobeglitazone

CKD501

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Related Publications (1)

• 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.

  PMID: 22697273 DERIVED

MeSH Terms

Interventions

Metformin; lobeglitazone

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Kyung S Yu

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: January 12, 2011

Record last verified: 2009-10