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

NCT02998437 | Completed Phase 1 DMC

• 1 other identifier: IY81149-DI03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Interaction Potentiation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Clarithromycin, Amoxicillin AUClast

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

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Ilaprazole 10mg

EXPERIMENTAL

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

Clarithromycin 500mg

ACTIVE COMPARATOR

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

Amoxicillin 500mg

ACTIVE COMPARATOR

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

Ilaprazole 10mg DRUG

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)

Ilaprazole 10mg

Clarithromycin 500mg DRUG

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)

Clarithromycin 500mg

Amoxicillin 500 Mg DRUG

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)

Amoxicillin 500mg

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead
• Severance Hospital: collaborator

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29846770 DERIVED

MeSH Terms

Interventions

ilaprazole; Clarithromycin; Amoxicillin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Min MS Park, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

KR (1)