Clinical Trial: A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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 Summary:
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
Sponsor: Boryung Pharmaceutical Co., Ltd
Current Primary Outcome: Cmax [ Time Frame: 0~120 hour after medication ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- tmax [ Time Frame: 0~120 hour after medication ]
- AUCinf [ Time Frame: 0~120 hour after medication ]
Original Secondary Outcome: Same as current
Information By: Boryung Pharmaceutical Co., Ltd
Dates:
Date Received: July 7, 2015
Date Started: July 2015
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016
