A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject

NCT ID: NCT01370681

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2009-11-30

Brief Summary

The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group1

Group Type: EXPERIMENTAL

Period I : HKB0701 and SLM0807, Period II : CJ30001

Intervention Type: DRUG

Group2

Group Type: EXPERIMENTAL

Period I : CJ30001, Period II : HKB0701 and SLM0807

Intervention Type: DRUG

Interventions

Period I : HKB0701 and SLM0807, Period II : CJ30001

Intervention Type: DRUG

Period I : CJ30001, Period II : HKB0701 and SLM0807

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
• Subjects with no history of any significant chronic disease
• Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
• Available for the entire study period
• Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria

• Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
• Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
• Subjects with a history of clinically significant allergies including drug allergies
• Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT >1.25 times to normal range or total bilirubin > 1.5times to normal range)
• Subjects with a history of drug, caffeine abuse(caffeine drink >5cups/day)
• Subjects with a history of alcohol abuse(alcohol>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration
• Heavy smoker ( >10cigarettes/day)
• Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
• Subjects who have donated plasma within 60days prior to drug administration
• Subjects who have participated in a clinical study within 90days prior to drug administration
• Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
• Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

CJ Cheiljedang Corporation

Principal Investigators

Jae Gook Shin, MD, ph D

Role: PRINCIPAL_INVESTIGATOR

Inje University

Other Identifiers

CJ_VCM_102

Identifier Type: -

Identifier Source: org_study_id