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A phase1 Clinical Trial to Evaluate the Safety and PK/PD of YH4808 After Postprandial Oral Administration in Healthy Volunteers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01761513
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

A clinical Study to evaluate the safety and pharmacokinetics/pharmacodynamics(PK/PD) of YH4808 after repeated Oral administration and Postprandial state in healthy volunteers


Condition Intervention Phase
Healthy
 Drug: YH4808
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized,Open Label,Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 After Postprandial Oral Administration in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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 0 ~ 24 hrs after administration ] [ Designated as safety issue: No ]
  • Peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 0~24 hrs after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach peak plasma concentration of YH4808 [ Time Frame: Blood sampling during 0 ~ 24 hrs after administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: YH4808

Group1

  1. adminitration of YH4808 dose1, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, qd for 2weeks
Drug: YH4808

Group2

  1. adminitration of YH4808 dose2, qd for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose1, bid for 2weeks
Drug: YH4808

Group3

  1. adminitration of YH4808 dose2, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of Nexium tab 40mg, bid for 2weeks
Other Name: YH4808, Nexium
Drug: YH4808

Group 4

  1. adminitration of Nexium tab 40mg, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, bid for 2weeks
Other Name: Nexium
Experimental: Sequence 2 Drug: YH4808

Group1

  1. adminitration of YH4808 dose1, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, qd for 2weeks
Drug: YH4808

Group2

  1. adminitration of YH4808 dose2, qd for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose1, bid for 2weeks
Drug: YH4808

Group3

  1. adminitration of YH4808 dose2, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of Nexium tab 40mg, bid for 2weeks
Other Name: YH4808, Nexium
Drug: YH4808

Group 4

  1. adminitration of Nexium tab 40mg, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, bid for 2weeks
Other Name: Nexium
Active Comparator: Sequence 3 Drug: YH4808

Group1

  1. adminitration of YH4808 dose1, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, qd for 2weeks
Drug: YH4808

Group2

  1. adminitration of YH4808 dose2, qd for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose1, bid for 2weeks
Drug: YH4808

Group3

  1. adminitration of YH4808 dose2, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of Nexium tab 40mg, bid for 2weeks
Other Name: YH4808, Nexium
Drug: YH4808

Group 4

  1. adminitration of Nexium tab 40mg, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, bid for 2weeks
Other Name: Nexium
Active Comparator: Sequence 4 Drug: YH4808

Group1

  1. adminitration of YH4808 dose1, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, qd for 2weeks
Drug: YH4808

Group2

  1. adminitration of YH4808 dose2, qd for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose1, bid for 2weeks
Drug: YH4808

Group3

  1. adminitration of YH4808 dose2, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of Nexium tab 40mg, bid for 2weeks
Other Name: YH4808, Nexium
Drug: YH4808

Group 4

  1. adminitration of Nexium tab 40mg, bid for 2weeks
  2. wash-out period for 3weeks between period1 and period2
  3. adminitration of YH4808 dose2, bid for 2weeks
Other Name: Nexium

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female aged 20 to 55 with a body mass index(BMI) between 18.5 and 25 kg/m2
  2. Subject who has no congenital, chronic diseases and disease symptoms in medical examination result
  3. Subject who shows negative reaction of UBT(Urea Breath Test)
  4. Subject who is judged to be eligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG etc) 4 weeks before the first IP adminitration
  5. Medically acceptable contraception(including individuals who are medically unable to become pregnant) used during the clinical trial
  6. Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug

Exclusion Criteria:

  1. Subject who is hypersensitive to components contained in YH4808 or this drug
  2. Subject who has history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood tumor, cardiovascular, urinary system, and mental disorder
  3. Subject who has history of surgical operation or diseases related to gastrointestinal symtem (e.g. crohn's disaese, ulcer etc except appendectomy or simple for herina)
  4. Other exclusions apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761513

Locations
Korea, Republic of
Yonsei University Health System(Severance Hospital)
Seoul, Seodaemun-gu,Sinchon-dong, Korea, Republic of, 120-752
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Minsoo Park, Ph.D, M.D. Yonsei University Health System(Severance Hospital)
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01761513     History of Changes
Other Study ID Numbers: YH4808-107
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013