A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare 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 HealthCare 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039896

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

No publications provided

Responsible Party: CJ HealthCare 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 July 23, 2014