Healthy, Pharmacokinetics of Atorvastatin
Conditions
Keywords
ASP1585, Drug-drug interaction, Atorvastatin, Healthy volunteer
Brief summary
This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2 crossover method.
Interventions
DRUGASP1585
oral
DRUGatorvastatin
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of atorvastatin | 48 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by AE, vital signs 12-lead ECG and lab tests | 7 days after administration |
Countries
Japan
Outcome results
None listed