Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Drug-Drug Interaction Study of TRK-100STP

This study has been completed.
Toray Industries, Inc
Information provided by:
Astellas Pharma Inc Identifier:
First received: July 18, 2008
Last updated: October 9, 2008
Last verified: October 2008

July 18, 2008
October 9, 2008
June 2008
September 2008   (final data collection date for primary outcome measure)
Pharmacokinetic profile [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00719758 on Archive Site
Safety parameters (vital signs, ECG, laboratory tests) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Drug-Drug Interaction Study of TRK-100STP
TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin

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

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.

Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Drug: TRK-100STP (BERASUS LA)
    Other Names:
    • beraprost
    • Careload LA
  • Drug: AST-120 (Kremezin®)
    Other Names:
    • Kremezin®
    • sopherical carbon adsorbent
Experimental: 1
Cross-over study
  • Drug: TRK-100STP (BERASUS LA)
  • Drug: AST-120 (Kremezin®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
  • Receives any investigational medicine within 120 days before screening
  • Recent blood donor
20 Years to 44 Years
Contact information is only displayed when the study is recruiting subjects
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Toray Industries, Inc
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP