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

Phase 1CompletedNCT01115972

Astellas Pharma Inc24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Pharmacokinetics of Valsartan

Interventions

ASP1585DRUG

oral

valsartanDRUG

oral

Eligibility

Sex: MALEMin age: 20 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Plasma concentration of valsartan

Time frame: for 48 hours after administration

Secondary Outcomes

Safety assessed by AE, vital signs 12-lead ECG and lab tests

Time frame: for 5 days after administration

Data from ClinicalTrials.gov

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