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

An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics After Administration of CJ30001 and Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001; Drug: Period I : CJ30001, Period II : HKB0701 and SLM0807

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1	Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001
Experimental: Group2	Drug: Period I : CJ30001, Period II : HKB0701 and SLM0807

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Geometric mean Cmax	up to 24hrs
Geometric mean AUCt	up to 24hrs

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Jae Gook Shin, MD, ph D, Inje University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): June 10, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: CJ_VCM_102