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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014