NCT02493738

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Superficial Mycoses
• Dermatomycoses
• Candidiasis
• Histoplasmosis

Interventions

Type	Name	Description
DRUG	Lozanoc 50mg	Lozanoc 50mg single dose under fed and fasted condition
DRUG	Sporanox 100mg	Sporanox 100mg single dose under fed condition

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-07-09
• Last updated: 2016-03-04

Locations

1 site across 1 country: South Korea