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OpenTrials
Completed

NCT Number: NCT01380873

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

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

Completed

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Drug

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

Drug

Primary outcomes

  1. AUC0-2h of plasma glucose

    Time frame: up to 2hrs

  2. △Cmax of plasma glucose

    Time frame: up to 2hrs

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 27, 2011
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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