NCT02052336

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

An Open-label, Randomized, 6-Sequence, 3-Period Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between CJ-12420 and Clarithromycin in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	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.
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.
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-11-01
• First posted: 2014-02-03
• Last updated: 2016-12-15

Locations

1 site across 1 country: South Korea