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Trial record 20 of 397 for:    CLARITHROMYCIN

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Clarithromycin, Amoxicillin and Ilaprazole (DDI)

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ClinicalTrials.gov Identifier: NCT02998437
Recruitment Status : Completed
First Posted : December 20, 2016
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
Severance Hospital
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date January 26, 2017
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Ilaprazole AUClast(Area Under the plasma concentration-time Curve at the last observed time point) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole Cmax(the maximum serum concentration) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin AUClast [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin Cmax [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
  • Ilaprazole AUClast [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole Cmax [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin AUClast [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin Cmax [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
Change History Complete list of historical versions of study NCT02998437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Ilaprazole AUCinf(Area Under the plasma concentration-time Curve from time zero to infinity) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole Tmax(the time to reach Cmax) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole t1/2(the elimination half-life) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole CL/F(the oral clearance) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole Vd/F(apparent volume of distribution after non-intravenous administration) [ Time Frame: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin AUCinf [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin Tmax [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin t1/2 [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin CL/F [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin Vd/F [ Time Frame: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
  • Ilaprazole AUCinf [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole Tmax [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole t1/2 [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole CL/F [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Ilaprazole Vd/F [ Time Frame: Predose(0h), afterdose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin AUCinf [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin Tmax [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin t1/2 [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin CL/F [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
  • Clarithromycin, Amoxicillin Vd/F [ Time Frame: Predose(0h), afterdose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Clarithromycin, Amoxicillin and Ilaprazole
Official Title  ICMJE A Randomized, Open-label, Parallel-design Study to Evaluate Pharmacokinetic Drug Interactions and Safety After Coadministration of Clarithromycin, Amoxicillin and Ilaprazole
Brief Summary This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin, Amoxicillin.
Detailed Description This study evaluate the pharmacokinetic drug interaction and safety in Ilaprazole, Clarithromycin, Amoxicillin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Drug Interaction Potentiation
Intervention  ICMJE
  • Drug: Ilaprazole 10mg
    Period 1: Ilaprazole 10mg, one a day, one day Period 2: Ilaprazole 10mg, twice a day, 6 days
    Other Name: Noltec(the brand name)
  • Drug: Clarithromycin 500mg
    Period 1: Clarithromycin 500mg 1 tab., twice a day, one day Period 2: Clarithromycin 500mg 1 tab., one a day at 5 day
    Other Name: Klaricid 500mg(the brand name)
  • Drug: Amoxicillin 500 Mg
    Period 1: Amoxicillin 500mg 2 cap., one a day, one day Period 2: Amoxicillin 500mg 2 cap., one a day at 5 day
    Other Name: Amoxicillin Cap. 500mg Chongkundang(the brand name)
Study Arms  ICMJE
  • Experimental: Ilaprazole 10mg

    Period 1: Ilaprazole 10mg 1 tab.m one a day

    Period 2: Clarithromycin 500mg 1 tab. + Amoxicillin 500mg 2 cap. twice a day, 6 days Ilaprazole 10mg, one a day at the 5 day

    Intervention: Drug: Ilaprazole 10mg
  • Active Comparator: Clarithromycin 500mg

    Period 1: Clarithromycin 500mg 1 tab. + Amoxicillin 500mg 2 cap., one a day

    Period 2: Ilaprazole 10mg 1 tab., twice a day, 6 days Clarithromycin 500mg 1 tab. + Amoxicillin 500mg 2 cap., one a day at the 5 day

    Intervention: Drug: Clarithromycin 500mg
  • Active Comparator: Amoxicillin 500mg

    Period 1: Clarithromycin 500mg 1 tab. + Amoxicillin 500mg 2 cap., one a day

    Period 2: Ilaprazole 10mg 1 tab., twice a day, 6 days Clarithromycin 500mg 1 tab. + Amoxicillin 500mg 2 cap., one a day at 5 day

    Intervention: Drug: Amoxicillin 500 Mg
Publications * Jin BH, Yoo BW, Park J, Kim JH, Lee JY, Shin JS, Park MS. Pharmacokinetic drug interaction and safety after coadministration of clarithromycin, amoxicillin, and ilaprazole: a randomised, open-label, one-way crossover, two parallel sequences study. Eur J Clin Pharmacol. 2018 Sep;74(9):1149-1157. doi: 10.1007/s00228-018-2489-2. Epub 2018 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2016)
32
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male adults aged ≥19 years and <50 years at screening
  2. Body mass index ≥18.5 and <25

    • Body mass index (kg/m2) = body weight (kg)/[height (m)]2
  3. Men who have sexual relationship with women of child bearing potential must give consent to using contraceptive measures (condoms, spermicide, and menstrual cycle control) and avoiding sperm donation during the study and up to 28 days following the last dose of IMP (these contraceptive measures are not required if the male subject or female partner is infertile).
  4. Those who voluntarily decided to participate in this study and gave written consent to comply with the requirements after receiving sufficient explanation and fully understanding this study.

Exclusion Criteria:

  1. Hypersensitivity or history of clinically significant hypersensitivity to active ingredients or excipients (in particular, Yellow No. 4 (Tartrazine); Yellow No. 5 (Sunset Yellow FCF); macrolide antibiotics such as Clarithromycin and erythromycin; or Penicillins)
  2. History of QT prolongation or ventricular arrhythmia (including Torsadedes de pointes)
  3. Clinically significant, current or past disorder of hepatobiliary (severe hepatic impairment, etc.), renal (severe renal impairment, etc.), nervous, immune, respiratory, endocrine, blood•tumor, cardiovascular (heart failure, etc.), or psychiatric system
  4. History of gastrointestinal disorder (Crohn's disease, ulcer, etc.) or operation (excluding simple appendectomy or herniotomy) that may affect drug absorption
  5. Administration of other IMP from other study (including biological comparability test) within 3 months of the first dose of IMP.
  6. Whole blood donation within 60 days, or apheresis donation within 30 days before the first dose of IMP.
  7. Constant caffeine intake (> 5 cups of coffee/day, > 1250 cc of tea/day, > 1250 cc of cola/day), constant smoking (more than 10 cigarettes/day) or constant alcohol drinking (more than 210 g/week) or inability to refrain from alcohol consumption from 2 days before the first dose of IMP until the end of PK assessment.
  8. Consumption of grapefruit-containing food within 7 days before the first dose of IMP
  9. History of drug abuse within 1 year before screening, or positive response in urine drug misuse/abuse screening test
  10. Use of medicinal products that are expected to or may affect the metabolism of IMP; St. John's wort; or relevant preparations within 30 days of IMP administration
  11. Use of following medicinal products within given time period excluding local preparations, which do not have significant systemic absorption, and hormonal contraceptives

    • Prescription drug within 14 days of the first dose of IMP
    • OTC including health supplements and vitamins within 7 days of the first dose of IMP
    • Medicinal products via depot injection or other implantations within 30 days of the first dose of IMP (excluding contraceptives)
    • Drug metabolizing enzyme inducer or inhibitor such as barbiturate within 30 days before the first dose of IMP
  12. Stable vital sign measured in sitting position at screening: systolic blood pressure > 150 mmHg or < 90 mmHg, diastolic blood pressure > 100 mmHg or < 50 mmHg, pulse rate > 110 bpm or <40 bpm
  13. Following findings at screening

    • Blood total bilirubin > 1.5 x upper limit of normal
    • Blood AST (SGOT), ALT (SGPT) > 1.25 x upper limit of normal
    • MDRD-estimated eGFR < 60 mL/min/1.73m2 eGFR (estimated glomerular filtration rate)(mL/min/1.73m2) = 175 x [serum creatinine (mg/dL)]-1.154 x [age (years)]-0.203
    • Positive serum test (hepatitis B, hepatitis C, HIV, syphilis)
  14. Those considered ineligible by the investigator due to other screening results or reasons.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02998437
Other Study ID Numbers  ICMJE IY81149-DI03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Il-Yang Pharm. Co., Ltd.
Study Sponsor  ICMJE Il-Yang Pharm. Co., Ltd.
Collaborators  ICMJE Severance Hospital
Investigators  ICMJE
Principal Investigator: Min MS Park, PhD Severance Hospital
PRS Account Il-Yang Pharm. Co., Ltd.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP