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Food Effect on Pharmacokinetics of YH4808 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01520012
First received: January 13, 2012
Last updated: July 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: YH4808 100 mg
Drug: YH4808 300 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Investigate the Influence of Food on Safety/Tolerability and Pharmacokinetics of YH4808 After Oral Administration in Healthy Male Subjects

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve of YH4808 [ Time Frame: Blood sampling during 24 or 48 hrs after administration ] [ Designated as safety issue: No ]
    non-compartmental analysis

  • Peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 24 or 48 hrs after administration ] [ Designated as safety issue: No ]
    non-compartmental analysis


Secondary Outcome Measures:
  • Time to reach peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 24 or 48 hrs after administration ] [ Designated as safety issue: No ]
    non-compartmental analysis


Enrollment: 44
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: YH4808 100 mg
Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days
Experimental: Sequence 2 Drug: YH4808 100 mg
Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days
Experimental: Sequence 3 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)
Experimental: Sequence 4 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)
Experimental: Sequence 5 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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520012

Locations
Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of, 156-754
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01520012     History of Changes
Other Study ID Numbers: YH4808-102
Study First Received: January 13, 2012
Last Updated: July 23, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014