A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment

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

2011-08-31

Study Completion Date

2014-02-28

Brief Summary

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The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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subjects with normal renal function

Group Type EXPERIMENTAL

beraprost sodium(BPS)

Intervention Type DRUG

patients with mild renal impairment

Group Type EXPERIMENTAL

beraprost sodium(BPS)

Intervention Type DRUG

patients with moderate renal impairment

Group Type EXPERIMENTAL

beraprost sodium(BPS)

Intervention Type DRUG

patients with severe renal impairment

Group Type EXPERIMENTAL

beraprost sodium(BPS)

Intervention Type DRUG

Interventions

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beraprost sodium(BPS)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The eGFR 1 day before study drug administration are stipulated as follows.
* Subjects with normal renal function : ≥90
* Patients with mild renal impairment : ≥60 to \<90
* Patients with moderate renal impairment : ≥30 to \<60
* Patients with severe renal impairment : ≥15 to \<30