Drug Interaction Between CKD-501 and Metformin

Healthy Male Volunteers Clinical Trial

— CKD-19HPS09H  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005160
• Other study ID #: CKD-19HPS09H
• Secondary ID: 19HPS09H
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2009
• Last updated: January 10, 2011
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2009
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Metformin
CKD-501 0.5mg, metformin 1000mg
• CKD-501
CKD-501 0.5mg, metformin 1000mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CKD - 501 and metformin Pharmacokinetics evaluation		16 days	No
Secondary	CKD-501 and metformin safety evaluation		16 days	No