MedTrace Logo

A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers

NCT02493738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-03-04

No results posted yet for this study

Summary

Study Objectives:

* To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects
* To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects
* To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects

Conditions

  • Superficial Mycoses
  • Dermatomycoses
  • Candidiasis
  • Histoplasmosis

Interventions

DRUG

Lozanoc 50mg

Lozanoc 50mg single dose under fed and fasted condition

DRUG

Sporanox 100mg

Sporanox 100mg single dose under fed condition

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Kyun-Seop Bae, M.D., Ph.D. · Department of Clinical Pharmacology and Therapeutics, Asan Medical Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • South Korea

Study Locations

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 NCT02493738 on ClinicalTrials.gov