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Drug-Drug Interaction Study of TRK-100STP

NCT ID: NCT00719758

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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TRK-100STP, beraprost sodium, Careload LA AST-120 Spherical carbon adsorbent Drug-drug interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cross-over study

Group Type EXPERIMENTAL

TRK-100STP (BERASUS LA)

Intervention Type DRUG

oral

AST-120 (Kremezin®)

Intervention Type DRUG

oral

Interventions

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TRK-100STP (BERASUS LA)

oral

Intervention Type DRUG

AST-120 (Kremezin®)

oral

Intervention Type DRUG

Other Intervention Names

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beraprost Careload LA BERASUS LA Kremezin® sopherical carbon adsorbent

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Toray Industries, Inc

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Inc.

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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533-CL-005

Identifier Type: -

Identifier Source: org_study_id