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

Candidiasis Clinical Trial

Official title:
A Phase I Single-Center, Randomized, Open-label, Single Dose, Crossover Study in Korean Healthy Male Volunteers to Evaluate Pharmacokinetics of Lozanoc and Sporanox

Clinical Trial 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

Clinical Trial Description

Phase I Study divided into 3 parts written as bellows.

Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02493738
Study type Interventional
Source Boryung Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date July 2015
Completion date October 2015
View Details
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