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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01115972
First received: May 3, 2010
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Healthy
Pharmacokinetics of Valsartan
Drug: ASP1585
Drug: valsartan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Valsartan -

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma concentration of valsartan [ Time Frame: for 48 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by AE, vital signs 12-lead ECG and lab tests [ Time Frame: for 5 days after administration ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single-add first group
single administration first, then concomitant administration
Drug: ASP1585
oral
Drug: valsartan
oral
Other Name: Diovan
Experimental: combi-add first group
concomitant administration first, then single administration
Drug: ASP1585
oral
Drug: valsartan
oral
Other Name: Diovan

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115972

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01115972     History of Changes
Other Study ID Numbers: 1585-CL-0009
Study First Received: May 3, 2010
Last Updated: May 26, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
ASP1585
Drug-drug interaction
valsartan
Healthy volunteer

Additional relevant MeSH terms:
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014