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Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520012
First Posted: January 27, 2012
Last Update Posted: July 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuhan Corporation
January 13, 2012
January 27, 2012
July 24, 2012
February 2012
May 2012   (Final data collection date for primary outcome measure)
  • Area under the plasma concentration versus time curve of YH4808 [ Time Frame: Blood sampling during 24 or 48 hrs after administration ]
    non-compartmental analysis
  • Peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 24 or 48 hrs after administration ]
    non-compartmental analysis
Same as current
Complete list of historical versions of study NCT01520012 on ClinicalTrials.gov Archive Site
Time to reach peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 24 or 48 hrs after administration ]
non-compartmental analysis
Same as current
Not Provided
Not Provided
 
Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects
Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects
The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: YH4808 100 mg
    Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days
  • Drug: YH4808 100 mg
    Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days
  • Drug: YH4808 300 mg
    Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)
  • Drug: YH4808 300 mg
    Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)
  • Drug: YH4808 300 mg
    Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition
  • Experimental: Sequence 1
    Intervention: Drug: YH4808 100 mg
  • Experimental: Sequence 2
    Intervention: Drug: YH4808 100 mg
  • Experimental: Sequence 3
    Intervention: Drug: YH4808 300 mg
  • Experimental: Sequence 4
    Intervention: Drug: YH4808 300 mg
  • Experimental: Sequence 5
    Intervention: Drug: YH4808 300 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
  • Healthy male volunteers in the age between 20 to 45 years old
  • Weight: over 50kg, within ±20% of ideal body weight
  • Subjects who were determined to be appropriate through screening

Exclusion Criteria:

  • Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
  • Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
  • A history of hypersensitivity to drugs or clinically significant allergic disease
  • Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
  • Subjects who had a history of drug abuse or who had a positive results on urine drug screening
  • Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
  • Subjects who participated in another clinical trial within 2 months before enrolling in this study
  • Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
  • Subjects who drank Over 21 units/week of alcohol or subjects who were unable to stop drinking alcohol during the hospitalization
  • Subjects who stopped smoking within 3 months before the treatment
  • Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
  • Subjects who had a beverage containing caffeine during the hospitalization
  • Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
Sexes Eligible for Study: Male
20 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01520012
YH4808-102
Yes
Not Provided
Not Provided
Yuhan Corporation
Yuhan Corporation
Not Provided
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University Hospital
Yuhan Corporation
May 2012

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