A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01039896
First received: December 23, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CJ Cheiljedang Corporation:

Primary Outcome Measures:
  • Css,max and AUCinf [ Time Frame: up to 24hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCtau, AUCt, Tmax [ Time Frame: up to 24hrs ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039896

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

No publications provided

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01039896     History of Changes
Other Study ID Numbers: CJ_VCM_101
Study First Received: December 23, 2009
Last Updated: February 11, 2013
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 April 15, 2014