A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject

This study has been completed.
Sponsor:
Information provided by:
CJ HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT01380873
First received: June 1, 2011
Last updated: June 23, 2011
Last verified: June 2011

June 1, 2011
June 23, 2011
January 2010
February 2010   (final data collection date for primary outcome measure)
  • AUC0-2h of plasma glucose [ Time Frame: up to 2hrs ] [ Designated as safety issue: No ]
  • △Cmax of plasma glucose [ Time Frame: up to 2hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01380873 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject
Not Provided

This trial is conducted to

  1. assess whether SLM0807 alters pharmacodynamics of HKB0701
  2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and multiple co-administration of HKB0701/SLM0807 in healthy subject
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Diabetes Mellitus
  • Drug: Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001
  • Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701
  • Drug: Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807
  • Experimental: Group1
    Intervention: Drug: Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001
  • Experimental: Group2
    Intervention: Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701
  • Experimental: Group3
    Intervention: Drug: Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01380873
CJ_VCM_103
No
Geun Seog, Song / Director of Regulatory and Clinical Development, CJ Cheiljedang Corporation
CJ HealthCare Corporation
Not Provided
Principal Investigator: Jae Gook Shin, MD, ph D Inje University
CJ HealthCare Corporation
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP