Drug-Drug Interaction Study of TRK-100STP

This study has been completed.
Sponsor:
Collaborator:
Toray Industries, Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00719758
First received: July 18, 2008
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Healthy
Drug: TRK-100STP (BERASUS LA)
Drug: AST-120 (Kremezin®)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety parameters (vital signs, ECG, laboratory tests) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cross-over study
Drug: TRK-100STP (BERASUS LA)
oral
Other Names:
  • beraprost
  • Careload LA
  • BERASUS LA
Drug: AST-120 (Kremezin®)
oral
Other Names:
  • Kremezin®
  • sopherical carbon adsorbent

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.

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719758

Locations
Japan
Tokyo, Japan, 108-8642
Sponsors and Collaborators
Astellas Pharma Inc
Toray Industries, Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00719758     History of Changes
Other Study ID Numbers: 533-CL-005
Study First Received: July 18, 2008
Last Updated: October 9, 2008
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
TRK-100STP,
beraprost sodium,
Careload LA
AST-120
Spherical carbon adsorbent
Drug-drug interaction

Additional relevant MeSH terms:
Beraprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 21, 2014