Reflux Clinical Trial
Official title:
A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355
Verified date | January 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Provision of signed informed consent - Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment Exclusion Criteria: - History of heart disease - Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Sweden | Research Site | Linkoping | |
Sweden | Research Site | Lulea | |
Sweden | Research | Uppsala |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic blood samples | 15 samples during 0-72 hours | No | |
Secondary | Pharmacokinetic urine samples | 8 samples during 72 hours | No |
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