A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers

NCT ID: NCT01115946

Last Updated: 2010-05-27

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

2010-03-31

Study Completion Date

2010-04-30

Brief Summary

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This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.

Detailed Description

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Conditions

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Healthy Pharmacokinetics of Enalapril

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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single-add first group

single administration first, then concomitant administration

Group Type EXPERIMENTAL

ASP1585

Intervention Type DRUG

oral

enalapril

Intervention Type DRUG

oral

combi-add first group

concomitant administration first, then single administration

Group Type EXPERIMENTAL

ASP1585

Intervention Type DRUG

oral

enalapril

Intervention Type DRUG

oral

Interventions

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ASP1585

oral

Intervention Type DRUG

enalapril

oral

Intervention Type DRUG

Other Intervention Names

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Renivace

Eligibility Criteria

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Inclusion Criteria

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases
Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma, Inc

Principal Investigators

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Use 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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1585-CL-0008

Identifier Type: -

Identifier Source: org_study_id

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