NCT02101710

Pharmacokinetic Properties of Isosorbide-5-mononitrate Under Fasting and Fed Condition in Healthy Male Subjects

A Randomized, Open-label, One Dose, 2-way Crossover Study to Evaluate the Bioequivalence of Elantan SR* 60 mg in Comparison With Imdur SR* 60 mg Under Fasted and Fed Conditions in Healthy Korean Male Subjects (*Sustained Release)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: UCB Korea Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects.

Detailed description

This study is to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects. Thirty subjects will be participating in a fasted state and other thirty subjects will be in a fed state. Elantan SR 60 mg and Imdur 60 mg are two formulations of Isosorbide 5-mononitrate.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Elantan SR 60 mg	* Trade Name: Elantan * Active Substance: Isosorbide 5-mononitrate * Pharmaceutical form: Tablet * Concentration: 60 mg * Route of Administration: Oral administration
DRUG	Imdur SR 60 mg	* Trade Name: Elantan * Active Substance: Isosorbide 5-mononitrate * Pharmaceutical form: Tablet * Concentration: 60 mg * Route of Administration: Oral administration

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2014-04-02
• Last updated: 2014-04-17

Locations

1 site across 1 country: South Korea