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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
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This study evaluate the pharmacokinetic drug interaction in Ilaprazole, Clarithromycin, Amoxicillin.
This study evaluate the pharmacokinetic drug interaction and safety in Ilaprazole, Clarithromycin, Amoxicillin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilaprazole 10mg | Drug | Period 1: Ilaprazole 10mg, one a day, one day Period 2: Ilaprazole 10mg, twice a day, 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Healthy male adults aged ≥19 years and <50 years at screening
Body mass index ≥18.5 and <25
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.
Exclusion Criteria:
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
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
Those considered ineligible by the investigator due to other screening results or reasons.
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| Name | Affiliation | Role |
|---|---|---|
| Min MS Park, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29846770 | Derived | 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. |
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| ID | Term |
|---|---|
| C119615 | ilaprazole |
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| 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 |
|
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| 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 |
|
|
| 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 |
| Clarithromycin, Amoxicillin AUCinf | Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h |
| Clarithromycin, Amoxicillin Tmax | Predose(0h), after dose 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48h |
| 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 |
| 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 |
| 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 |
| Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |