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

Il-Yang Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Drug Interaction Potentiation

Treatments: Drug: Clarithromycin 500mg; Drug: Ilaprazole 10mg; Drug: Amoxicillin 500 Mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02998437

IY81149-DI03

Details and patient eligibility

About

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

Full description

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

Enrollment: 28 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Ilaprazole 10mg

Experimental group

Description:

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

Treatment:

Drug: Ilaprazole 10mg

Clarithromycin 500mg

Active Comparator group

Description:

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

Treatment:

Drug: Clarithromycin 500mg

Amoxicillin 500mg

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin 500 Mg