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Drug-Drug Interaction Study of TRK-100STP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719758
First Posted: July 22, 2008
Last Update Posted: October 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Toray Industries, Inc
Information provided by:
Astellas Pharma Inc
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Safety parameters (vital signs, ECG, laboratory tests) [ Time Frame: 1 day ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00719758     History of Changes
Other Study ID Numbers: 533-CL-005
First Submitted: July 18, 2008
First Posted: July 22, 2008
Last Update Posted: October 13, 2008
Last Verified: October 2008

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
Epoprostenol
Platelet Aggregation Inhibitors
Vasodilator Agents
Antihypertensive Agents