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Trial record 41 of 353 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.

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

Condition or disease Intervention/treatment Phase
Drug Interaction Potentiation 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02998437


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Severance Hospital
Investigators
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Principal Investigator: Min MS Park, PhD Severance Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02998437     History of Changes
Other Study ID Numbers: IY81149-DI03
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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