- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380873
A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject
June 23, 2011 updated by: HK inno.N Corporation
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group1
|
|
Experimental: Group2
|
|
Experimental: Group3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC0-2h of plasma glucose
Time Frame: up to 2hrs
|
up to 2hrs
|
△Cmax of plasma glucose
Time Frame: up to 2hrs
|
up to 2hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jae Gook Shin, MD, ph D, Inje University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
June 23, 2011
First Posted (Estimate)
June 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- CJ_VCM_103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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