The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects

NCT01921647 | Completed Phase 1

• 1 other identifier: YH4808-108
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

safety/tolerability and pharmacokinetics/pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Cmax, AUClast of YH4808, M3, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

  pre dose, 16 times after dosing

Secondary Outcomes (1)

• Cmax, AUClast of M8, AUCinf, t1/2, Tmax of YH4808, M3, M8, amoxicillin, clarithromycin, 14-hydroxyclarithromycin

  pre dose, 16 times after dosing

Study Arms (4)

YH4808, amoxicillin, clarithromycin

EXPERIMENTAL

single administration of YH4808 or amoxicillin or clarithromycin or YH4808 + amoxicillin + clarithromycin

Drug: YH4808; Drug: Amoxicillin; Drug: clarithromycin

YH4808, amoxicillin and clarithromycin

EXPERIMENTAL

7 days repeat administration of YH4808, amoxicillin and clarithromycin for H.pylori eradication

Drug: YH4808; Drug: Amoxicillin; Drug: clarithromycin

YH4808 and amoxicillin

EXPERIMENTAL

7 days repeat administration of YH4808 and amoxicillin for H.pylori eradication

Drug: YH4808; Drug: Amoxicillin

nexium, amoxicillin and clarithromycin

ACTIVE COMPARATOR

BID, 7 days repeat administration of nexium, amoxicillin and clarithromycin for H.pylori eradication

Drug: Nexium; Drug: Amoxicillin; Drug: clarithromycin

Interventions

YH4808 DRUG

Also known as: experimental drug

YH4808 and amoxicillin; YH4808, amoxicillin and clarithromycin; YH4808, amoxicillin, clarithromycin

Nexium DRUG

Also known as: active comparator

nexium, amoxicillin and clarithromycin

Amoxicillin DRUG

Also known as: experimental drug

YH4808 and amoxicillin; YH4808, amoxicillin and clarithromycin; YH4808, amoxicillin, clarithromycin; nexium, amoxicillin and clarithromycin

clarithromycin DRUG

Also known as: experimental drug

YH4808, amoxicillin and clarithromycin; YH4808, amoxicillin, clarithromycin; nexium, amoxicillin and clarithromycin

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Yonsei University Severance Hospital

Seoul, South Korea

Location

Related Publications (2)

• Park H, Kim CO, Kim M, Lim Y, Lee WY, Yoon S, Park MS. Pharmacodynamic evaluation of YH4808 for Helicobacter pylori eradication in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):136-146. doi: 10.12793/tcp.2020.28.e16. Epub 2020 Sep 23.

  PMID: 33062627 DERIVED

• Lee WY, Oh E, Cui M, Kim CO, Lim Y, Kim H, Park H, Yoon S, Park MS, Hong T. Evaluation of pharmacokinetic interactions between amoxicillin, clarithromycin, and the potassium-competitive acid blocker YH4808 in healthy subjects. Transl Clin Pharmacol. 2020 Mar;28(1):55-65. doi: 10.12793/tcp.2020.28.e5. Epub 2020 Mar 31.

  PMID: 32274381 DERIVED

MeSH Terms

Interventions

YH4808; Drugs, Investigational; Esomeprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Min soo Park, Ph.D, M.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 13, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

KR (1)