A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject | NCT01380873 | Trialant
CompletedInterventionalPhase 1Updated Jun 27, 2011
A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject
ClinicalTrials.gov ID
NCT01380873
Lead Sponsor
HK inno.N CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
30Actual
Last Update Posted
Jun 27, 2011Estimated
Start Date
Jan 2010
Primary Completion Date
Feb 2010Actual
Completion Date
Mar 2010Actual
Brief Summary
This trial is conducted to
assess whether SLM0807 alters pharmacodynamics of HKB0701
estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and multiple co-administration of HKB0701/SLM0807 in healthy subject
Diabetes Mellitus
Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001
Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701
Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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
Subjects with FPG<100mg/dL and 2hr glucose after 75g OGTT<140mg/dL
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 drank alcohol within 7 days 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