ClinicalTrials.gg
Sign In
CompletedNCT02998437DDIUpdated Jan 26, 2017

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

A Phase 1 interventional study of Ilaprazole 10mg and Clarithromycin 500mg in Drug Interaction Potentiation, sponsored by Il-Yang Pharm. Co., Ltd.. Completed at 1 site in South Korea. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
Male
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Drug Interaction Potentiation
03

In context

Lead sponsor

Il-Yang Pharm. Co., Ltd. is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Browse Il-Yang Pharm. Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugIlaprazole 10mg

    Period 1: Ilaprazole 10mg, one a day, one day Period 2: Ilaprazole 10mg, twice a day, 6 days

    Also known as: Noltec(the brand name)

  • DrugClarithromycin 500mg

    Period 1: Clarithromycin 500mg 1 tab., twice a day, one day Period 2: Clarithromycin 500mg 1 tab., one a day at 5 day

    Also known as: Klaricid 500mg(the brand name)

  • DrugAmoxicillin 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

    Also known as: Amoxicillin Cap. 500mg Chongkundang(the brand name)

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Severance Hospital
    Seoul, South Korea
08

References and documents

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. PubMed 29846770 ↗

Individual participant data

Plan to share: Undecided — Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Jan 2017, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2016
First posted
Dec 20, 2016
StartActual
Dec 2016
Primary completionActual
Jan 2017
CompletionActual
Jan 2017
Last update
Jan 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02998437
Lead sponsor
Il-Yang Pharm. Co., Ltd.
Collaborators
Severance Hospital
Responsible party
Sponsor
First posted
Dec 20, 2016
Start date
Dec 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jan 26, 2017

Study contacts

Min MS Park, PhD
principal investigator · Severance Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Ilaprazole · Amoxicillin

Other studies from this sponsor

Il-Yang Pharm. Co., Ltd. →

Start the discussion