Text Size

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

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

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

Condition Intervention Phase
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
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by CJ Cheiljedang Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group1 Drug: Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001
Experimental: Group2 Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701
Experimental: Group3 Drug: Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380873

Sponsors and Collaborators
CJ Cheiljedang Corporation
Investigators
Principal Investigator: Jae Gook Shin, MD, ph D Inje University
  More Information

No publications provided

Responsible Party: Geun Seog, Song / Director of Regulatory and Clinical Development, CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01380873     History of Changes
Other Study ID Numbers: CJ_VCM_103
Study First Received: June 1, 2011
Last Updated: June 23, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013