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

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of Valsartan; Healthy

Treatments: Drug: ASP1585; Drug: valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115972

1585-CL-0009

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

single-add first group

Experimental group

Description:

single administration first, then concomitant administration

Treatment:

Drug: valsartan

Drug: ASP1585

combi-add first group

Experimental group

Description:

concomitant administration first, then single administration

Treatment:

Drug: valsartan

Drug: ASP1585