A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation

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 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