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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370681
• Other study ID #: CJ_VCM_102
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2011
• Last updated: June 9, 2011
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: June 2011
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Period I : HKB0701 and SLM0807, Period II : CJ30001

• Period I : CJ30001, Period II : HKB0701 and SLM0807

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean Cmax		up to 24hrs	No
Primary	Geometric mean AUCt		up to 24hrs	No