Status:
COMPLETED
Drug-Drug Interaction Study of TRK-100STP
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Toray Industries, Inc
Conditions:
Healthy
Eligibility:
MALE
20-44 years
Phase:
PHASE1
Brief 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-1...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg
Exclusion
- Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
- Receives any investigational medicine within 120 days before screening
- Recent blood donor
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00719758
Start Date
June 1 2008
End Date
September 1 2008
Last Update
October 13 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tokyo, Japan, 108-8642