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NCT02052336

Drug-Drug Interaction Study Between CJ-12420 and Clarithromycin in Healthy Male Subjects

NCT ID: NCT02052336

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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Primary Objective: To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Secondary Objective(s): To assess the safety of the coadministration of multiple dose of CJ-12420 and clarithromycin in healthy subjects

Detailed Description

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An open-label, randomized, 6-sequence, 3-period, 3-treatment crossover design

Conditions

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Healthy

Keywords

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Drug-Drug interaction Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CJ-12420 200 mg + Clarithromycin 500mg

CJ-12420 200mg QD for 5 days + Clarithromycin 500mg BID for 5 days

Group Type EXPERIMENTAL

CJ-12420 200mg

Intervention Type DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Clarithromycin 500mg

Intervention Type DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

CJ-12420 200mg

CJ-12420 200mg QD for 5 days

Group Type ACTIVE_COMPARATOR

CJ-12420 200mg + Clarithromycin 500mg

Intervention Type DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Clarithromycin 500mg

Intervention Type DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Clarithromycin 500mg

Clarithromycin 500mg BID for 5 days

Group Type ACTIVE_COMPARATOR

CJ-12420 200mg + Clarithromycin 500mg

Intervention Type DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

CJ-12420 200mg

Intervention Type DRUG

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Interventions

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CJ-12420 200mg + Clarithromycin 500mg

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Intervention Type DRUG

CJ-12420 200mg

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Intervention Type DRUG

Clarithromycin 500mg

To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.

Intervention Type DRUG

Other Intervention Names

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CJ-12420 200mg for 5 days + Clarithromycin 500mg for 5 days CJ-12420 200mg for 5 days Clarithromycin 500mg for 5 days

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers in the age between 19 and 45 years old
* Body mass index(BMI) in the range of 19 to 28 kg/m2
* Understand the requirement of the study and voluntarily consent to paticipate in the study

Exclusion Criteria

* History of clinically significant medical history or disease (hepatic, kidney, gastrointestinal,respiratory, musculoskeletal, endocrine,neuro-psychiatric, haemato-oncologic,urinary tract, cardiac arrhythmia and cardiovascular system) judged by investigator.
* Clinically significant abnormal laboratory results within at least 28 days prior to the first day of drug administration. AST or ALT \> 1.25 times of upper limit value Total bilirubin \> 1.5 times of upper limit value estimated GFR :less than 80 mL/min
* Clinically significant abnormal ECG results within at least 28 days prior to the first day of drug administration PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 500 msec
* Clinically significant hypersensitivity reaction against investigational drug or other drugs
* history of drug abuse or "positive" results from drug screening test.
* Take medicine such as prescription medicine or herbal medicine, over-the-counter drug, vitamin supplements
* Person who have intake history of food or drug which can affect drug absorption, drug distribution, drug metabolism, and drug excretion and bowel activity
* Volunteer have a history of donation of whole blood donation, apheresis, transfusion
* Volunteer a heavy drinker(30g/day), smoker(10 cigarettes/day), heavy caffeine consumer(400mg/day)

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inje university college of medicine Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

References

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Oh M, Lee H, Kim S, Kim B, Song GS, Shin JG, Ghim JL. Evaluation of pharmacokinetic drug-drug interaction between tegoprazan and clarithromycin in healthy subjects. Transl Clin Pharmacol. 2023 Jun;31(2):114-123. doi: 10.12793/tcp.2023.31.e11. Epub 2023 Jun 27.

Reference Type DERIVED

PMID: 37440779 (View on PubMed)

Other Identifiers

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CJ_APA_103

Identifier Type: -

Identifier Source: org_study_id