A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers
Phase 1
Completed
- Conditions
- HealthyPharmacokinetics of Enalapril
- Interventions
- Registration Number
- NCT01115946
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description combi-add first group enalapril concomitant administration first, then single administration single-add first group ASP1585 single administration first, then concomitant administration combi-add first group ASP1585 concomitant administration first, then single administration single-add first group enalapril single administration first, then concomitant administration
- Primary Outcome Measures
Name Time Method Plasma concentration of enalapril for 48 hours after administration
- Secondary Outcome Measures
Name Time Method Safety assessed by AE, vital signs 12-lead ECG and lab tests for 7 days after administration