- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115946
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Enalapril in Healthy Volunteers
May 26, 2010 updated by: Astellas Pharma Inc
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Enalapril -
This study is to assess the effect of ASP1585 on pharmacokinetics of enalapril in 2x2 crossover method.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-add first group
single administration first, then concomitant administration
|
oral
oral
Other Names:
|
Experimental: combi-add first group
concomitant administration first, then single administration
|
oral
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of enalapril
Time Frame: for 48 hours after administration
|
for 48 hours after administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety assessed by AE, vital signs 12-lead ECG and lab tests
Time Frame: for 7 days after administration
|
for 7 days after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
May 3, 2010
First Submitted That Met QC Criteria
May 3, 2010
First Posted (Estimate)
May 4, 2010
Study Record Updates
Last Update Posted (Estimate)
May 27, 2010
Last Update Submitted That Met QC Criteria
May 26, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1585-CL-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on ASP1585
-
Astellas Pharma IncCompletedHealthy | Pharmacokinetics of ASP1585United States
-
Astellas Pharma IncCompletedRenal Insufficiency | Chronic Kidney Disease | Hyperphosphatemia | Renal DialysisJapan
-
Astellas Pharma IncCompletedA Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal DialysisRenal Insufficiency | Chronic Kidney Disease | Renal DialysisJapan
-
Astellas Pharma IncCompletedHealthy | Urine Phosphorus ExcretionJapan
-
Astellas Pharma IncCompleted
-
Astellas Pharma IncCompletedChronic Kidney DiseaseJapan
-
Astellas Pharma IncCompletedChronic Kidney Disease Patients on Hemodialysis With HyperphosphatemiaJapan
-
Astellas Pharma IncCompletedRenal Insufficiency | Chronic Kidney Disease | HyperphosphatemiaJapan
-
Astellas Pharma IncCompletedA Phase 3 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia Not on DialysisRenal Insufficiency | Chronic Kidney Disease | HyperphosphatemiaJapan
-
Astellas Pharma IncCompletedChronic Renal Failure Patients With Hyperphosphataemia Receiving HemodialysisJapan