MedTrace Logo

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

NCT02101710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-04-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Seoul Pharma Laboratories Inc.

    collaborator INDUSTRY

  • UCB Korea Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • South Korea

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101710 on ClinicalTrials.gov