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

December 23, 2009
February 11, 2013
June 2009
July 2009   (final data collection date for primary outcome measure)
Css,max and AUCinf [ Time Frame: up to 24hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01039896 on ClinicalTrials.gov Archive Site
AUCtau, AUCt, Tmax [ Time Frame: up to 24hrs ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of concomitant administration of HKB0701 and SLM0807 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Diabetes Mellitus
  • Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807
  • Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807
  • Experimental: Group1
    SLM0807
    Intervention: Drug: Period I : SLM0807, Period II : HKB0701 and SLM0807
  • Experimental: Group2
    SLM0807 and HKB0701
    Intervention: Drug: Period I : HKB0710 and SLM0807, Period II : SLM0807
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2009
July 2009   (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
  • 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
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01039896
CJ_VCM_101
No
CJ HealthCare Corporation
CJ HealthCare Corporation
Not Provided
Principal Investigator: Jae Gook Shin, MD, ph D Inje University
CJ HealthCare Corporation
February 2013

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