A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject

This study has been completed.
Sponsor:
Information provided by:
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01370681
First received: June 1, 2011
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.


Condition Intervention Phase
Diabetes Mellitus
Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001
Drug: Period I : CJ30001, Period II : HKB0701 and SLM0807
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics After Administration of CJ30001 and 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:
  • Geometric mean Cmax [ Time Frame: up to 24hrs ] [ Designated as safety issue: No ]
  • Geometric mean AUCt [ Time Frame: up to 24hrs ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group1 Drug: Period I : HKB0701 and SLM0807, Period II : CJ30001
Experimental: Group2 Drug: Period I : CJ30001, Period II : 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
  • 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 drinked alcohol whinin 7days 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: NCT01370681

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: NCT01370681     History of Changes
Other Study ID Numbers: CJ_VCM_102
Study First Received: June 1, 2011
Last Updated: June 9, 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 April 17, 2014