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Completed

NCT Number: NCT01115985

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

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

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Key information

Conditions

Healthy Pharmacokinetics of Atorvastatin

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP1585

Drug

oral

atorvastatin

Drug

oral

Other names: Lipitor

Primary outcomes

  1. Plasma concentration of atorvastatin

    Time frame: 48 hours after administration

Secondary outcomes

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

    Time frame: 7 days after administration

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 4, 2010
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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