A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy; Pharmacokinetics of Atorvastatin
Intervention: ASP1585 (Drug); atorvastatin (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 atorvastatin in 2x2
crossover method.
Clinical Details
Official title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Plasma concentration of atorvastatin
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
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