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

Phase 1

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01370681
• Lead Sponsor: HK inno.N Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-06
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-09
• Last Update Submitted: 2011-06-09
• Study First Posted: 2011-06-10
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Geometric mean Cmax	up to 24hrs
Geometric mean AUCt	up to 24hrs