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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: YH4808 Drug: Nexium Drug: Amoxicillin Drug: clarithromycin | Phase 1 |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy male age 20 to 55 over 55kg with Ideal body weight(BMI:18.5~25)
- Subject who has no congenital, chronic disease and disease symptoms in medical examination result
- 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:
- Subject who is hypersensitive to components contained in YH4808 or this drug
- 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
- 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)
- Other exclusions apply

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
Korea, Republic of | |
Yonsei University Severance Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Min soo Park, Ph.D, M.D. | Severance Hospital |
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 |
safety/tolerability and pharmacokinetics/pharmacodynamics |
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 |