NCT00719758

Drug-Drug Interaction Study of TRK-100STP

TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Detailed description

Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TRK-100STP (BERASUS LA)	oral
DRUG	AST-120 (Kremezin®)	oral

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-07-22
• Last updated: 2008-10-13

Locations

1 site across 1 country: Japan