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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy; Pharmacokinetics of Valsartan

Intervention: ASP1585 (Drug); valsartan (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Summary

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

Clinical Details

Official title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Valsartan -

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Plasma concentration of valsartan

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

Eligibility

Minimum age: 20 Years. Maximum age: 44 Years. Gender(s): Male.

Criteria:

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 and Contacts

Tokyo, Japan
Additional Information

Starting date: March 2010
Last updated: May 26, 2010

Page last updated: August 20, 2015

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