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The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects (YH4808-108)

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.
 
ClinicalTrials.gov Identifier: NCT01921647
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Study Description
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Brief Summary:
The objective of this study is not only to explore pharmacokinetic interaction after single oral administration but also pharmacodynamics interaction after multiple oral administration of YH4808, amoxicillin and clarithromycin each separately versus coadministration of YH4808, amoxicillin and clarithromycin in healthy volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: YH4808 Drug: Nexium Drug: Amoxicillin Drug: clarithromycin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Exploration for Pharmacodynamics and Pharmacokinetic Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects
Study Start Date : July 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: YH4808, amoxicillin, clarithromycin
single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin
 Drug: YH4808
Other Name: experimental drug

Drug: Amoxicillin
Other Name: experimental drug

Drug: clarithromycin
Other Name: experimental drug
Experimental: YH4808, amoxicillin and clarithromycin
7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication
 Drug: YH4808
Other Name: experimental drug

Drug: Amoxicillin
Other Name: experimental drug

Drug: clarithromycin
Other Name: experimental drug
Experimental: YH4808 and amoxicillin
7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication
 Drug: YH4808
Other Name: experimental drug

Drug: Amoxicillin
Other Name: experimental drug
Active Comparator: nexium, amoxicillin and clarithromycin
BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication
 Drug: Nexium
Other Name: active comparator

Drug: Amoxicillin
Other Name: experimental drug

Drug: clarithromycin
Other Name: experimental drug


Outcome Measures
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Primary Outcome Measures :
  1. Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin [ Time Frame: pre dose, 16 times after dosing ]

Secondary Outcome Measures :
  1. Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin [ Time Frame: pre dose, 16 times after dosing ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
  2. Subject who has no congenital, chronic disease and disease symptoms in medical examination result
  3. 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, 12-lead GCG etc)

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 symptom (e.g. Crohn's disease, ulcer etc except appendectomy or simple for hernia)
  4. Other exclusions apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921647


Locations
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Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Min soo Park, Ph.D, M.D. Severance Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01921647    
Other Study ID Numbers: YH4808-108
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013
Keywords provided by Yuhan Corporation:
safety/tolerability and pharmacokinetics/pharmacodynamics
Additional relevant MeSH terms:
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Amoxicillin
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors