A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT01039896
• Lead Sponsor: HK inno.N Corporation

Brief Summary

The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-25
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 or alcohol abuse (caffeine drink >5cups /day, alcohol >30g/day)
• 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 (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
Css,max and AUCinf	up to 24hrs

Secondary Outcome Measures

Name	Time	Method
AUCtau, AUCt, Tmax	up to 24hrs