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AzTrials

Drug Interaction PotentiationPhase 1DDINCT02998437

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

A Phase 1 study testing Ilaprazole 10mg, Clarithromycin 500mg and Amoxicillin 500 Mg in people with Drug Interaction Potentiation, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin, Amoxicillin. Read more about this study

Who is it for?
Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Drug Interaction Potentiation
What is being tested?
Ilaprazole 10mg, Clarithromycin 500mg and Amoxicillin 500 Mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
Dec 2016to Jan 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male adults aged ≥19 years and <50 years at screening
  • Body mass index ≥18.5 and <25
  • Body mass index (kg/m2) = body weight (kg)/[height (m)]2
  • 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).
  • 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.

Who cannot join

  • 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)
  • History of QT prolongation or ventricular arrhythmia (including Torsadedes de pointes)
  • 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
  • History of gastrointestinal disorder (Crohn's disease, ulcer, etc.) or operation (excluding simple appendectomy or herniotomy) that may affect drug absorption
  • Administration of other IMP from other study (including biological comparability test) within 3 months of the first dose of IMP.
  • Whole blood donation within 60 days, or apheresis donation within 30 days before the first dose of IMP.
Show all 22Show fewer
  • 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.
  • Consumption of grapefruit-containing food within 7 days before the first dose of IMP
  • History of drug abuse within 1 year before screening, or positive response in urine drug misuse/abuse screening test
  • 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
  • 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
  • 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
  • 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)
  • Those considered ineligible by the investigator due to other screening results or reasons.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Parallel-design Study to Evaluate Pharmacokinetic Drug Interactions and Safety After Coadministration of Clarithromycin, Amoxicillin and Ilaprazole

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.

Being tested
Ilaprazole 10mg, Clarithromycin 500mg, Amoxicillin 500 Mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ilaprazole 10mgDrug

    Also called Noltec(the brand name)

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

  • Clarithromycin 500mgDrug

    Also called Klaricid 500mg(the brand name)

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

  • Amoxicillin 500 MgDrug

    Also called Amoxicillin Cap. 500mg Chongkundang(the brand name)

    Period 1: Amoxicillin 500mg 2 cap., one a day, one day Period 2: Amoxicillin 500mg 2 cap., one a day at 5 day

Study groups in NCT02998437
Study groupRoleWhat they receive
Ilaprazole 10mgExperimentalPeriod 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
Receives: Drug: Ilaprazole 10mg
Clarithromycin 500mgActive comparatorPeriod 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
Receives: Drug: Clarithromycin 500mg
Amoxicillin 500mgActive comparatorPeriod 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
Receives: Drug: Amoxicillin 500 Mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ilaprazole AUClast(Area Under the plasma concentration-time Curve at the last observed time point)

    Measured: 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)

    Measured: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h

  3. Clarithromycin, Amoxicillin AUClast

    Measured: 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

    Measured: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h

Secondary outcomes (10)

  1. Ilaprazole AUCinf(Area Under the plasma concentration-time Curve from time zero to infinity)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Predose(0h), after dose 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48h

  6. Clarithromycin, Amoxicillin AUCinf

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998437
Sponsor's protocol ID
IY81149-DI03
Acronym
DDI
Status last verified
Jan 2017
First submitted
22 Nov 2016
Last updated
26 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ilaprazole 10mg, Clarithromycin 500mg and Amoxicillin 500 Mg in people with Drug Interaction Potentiation, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.

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