NCT02531191

Bioequivalence Evaluation of a New and Current Tablet of ASP015K

ASP015K Pharmacokinetic Study - Bioequivalence Evaluation of a Small and Current Tablet of ASP015K

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.

Detailed description

This is an open-label, randomized, single dose, 2-way crossover designed study. Forty non-elderly healthy male subjects will receive an ASP015K small tablet or an ASP015K current tablet in each period under fasted conditions. If the bioequivalence between two tablets cannot be demonstrated because of an insufficient number, an add-on subject study will be conducted as needed. The design of the add-on subject study will be the same with that of the initial study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	peficitinib	oral

Timeline

• Start date: 2015-06-21
• Primary completion: 2015-07-15
• Completion: 2015-07-15
• First posted: 2015-08-24
• Last updated: 2024-10-16

Locations

1 site across 1 country: Japan