A Pharmacodynamic Study of SLM0807, HKB0701 and CJ30001 in Healthy Subject

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380873
• Other study ID #: CJ_VCM_103
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2011
• Last updated: June 23, 2011
• Start date: January 2010
• Est. completion date: March 2010

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

This trial is conducted to

1. assess whether SLM0807 alters pharmacodynamics of HKB0701

2. estimate the pharmacodynamics of HKB0701 after multiple administration of CJ30001 and multiple co-administration of HKB0701/SLM0807 in healthy subject

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• 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

• Subjects with FPG<100mg/dL and 2hr glucose after 75g OGTT<140mg/dL

• 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 drank alcohol within 7 days 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: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

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

• Period I : CJ30001, Period II : HKB0701, Period III : 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	AUC0-2h of plasma glucose		up to 2hrs	No
Primary	?Cmax of plasma glucose		up to 2hrs	No