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A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01039896
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : February 13, 2013
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807 Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized, Crossover Study to Evaluate the Safety and Pharmacokinetics After Multiple Administration of SLM0807 Alone and Multiple Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: Group1
SLM0807
Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807
Experimental: Group2
SLM0807 and HKB0701
Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807



Primary Outcome Measures :
  1. Css,max and AUCinf [ Time Frame: up to 24hrs ]

Secondary Outcome Measures :
  1. AUCtau, AUCt, Tmax [ Time Frame: up to 24hrs ]


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039896


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01039896     History of Changes
Other Study ID Numbers: CJ_VCM_101
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

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