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

Sponsor
Il-Yang Pharm. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02998437
Collaborator
Severance Hospital (Other)
28
Enrollment
1
Location
3
Arms
1
Actual Duration (Months)
27.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin, Amoxicillin.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ilaprazole 10mg
  • Drug: Clarithromycin 500mg
  • Drug: Amoxicillin 500 Mg
 Phase 1

Detailed Description

This study evaluate the pharmacokinetic drug interaction and safety in Ilaprazole, Clarithromycin, Amoxicillin.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Parallel-design Study to Evaluate Pharmacokinetic Drug Interactions and Safety After Coadministration of Clarithromycin, Amoxicillin and Ilaprazole
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Ilaprazole 10mg
Period 1: Ilaprazole 10mg, one a day, one day Period 2: Ilaprazole 10mg, twice a day, 6 days
Other Names:
  • Noltec(the brand name)

    		•
    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

    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 Names:
  • Klaricid 500mg(the brand name)

    		•
    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

    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 Names:
  • Amoxicillin Cap. 500mg Chongkundang(the brand name)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ilaprazole AUClast(Area Under the plasma concentration-time Curve at the last observed time point) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    2. Ilaprazole Cmax(the maximum serum concentration) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    3. Clarithromycin, Amoxicillin AUClast [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    4. Clarithromycin, Amoxicillin Cmax [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    Secondary Outcome Measures

    1. Ilaprazole AUCinf(Area Under the plasma concentration-time Curve from time zero to infinity) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    2. Ilaprazole Tmax(the time to reach Cmax) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    3. Ilaprazole t1/2(the elimination half-life) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    4. Ilaprazole CL/F(the oral clearance) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    5. Ilaprazole Vd/F(apparent volume of distribution after non-intravenous administration) [Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h]

    6. Clarithromycin, Amoxicillin AUCinf [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    7. Clarithromycin, Amoxicillin Tmax [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    8. Clarithromycin, Amoxicillin t1/2 [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    9. Clarithromycin, Amoxicillin CL/F [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    10. Clarithromycin, Amoxicillin Vd/F [Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    1. 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).

    2. 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

    1. 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

    2. 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)

    1. Those considered ineligible by the investigator due to other screening results or reasons.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Il-Yang Pharm. Co., Ltd.
    • Severance Hospital

    Investigators

    • Principal Investigator: Min MS Park, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Il-Yang Pharm. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02998437
    Other Study ID Numbers:
    • IY81149-DI03
    First Posted:
    Dec 20, 2016
    Last Update Posted:
    Jan 26, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Amoxicillin
    Clarithromycin

    Study Results

    No Results Posted as of Jan 26, 2017