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OpenTrials
Completed

NCT Number: NCT00719758

Drug-Drug Interaction Study of TRK-100STP

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

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Key information

Conditions

Healthy

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, 108-8642, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRK-100STP (BERASUS LA)

Drug

oral

Other names: beraprost, Careload LA, BERASUS LA

AST-120 (Kremezin®)

Drug

oral

Other names: Kremezin®, sopherical carbon adsorbent

Primary outcomes

  1. Pharmacokinetic profile

    Time frame: 1 day

Secondary outcomes

  1. Safety parameters (vital signs, ECG, laboratory tests)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Toray Industries, Inc

Registry information

Official study title

TRK-100STP Pharmacokinetic Study in Healthy Volunteers - Evaluation of Pharmacokinetic Interaction Between TRK-100STP and Kremezin

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 22, 2008
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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