Renal impairment study

Study identifier:D9120C00022

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Reflux

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3355

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Mar 2009

Primary Completion Date: 01 Feb 2010

Study Completion Date: 01 Feb 2010

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 AZD3355 65 + 65 mg capsule	Drug: AZD3355 capsule, oral, single dose Other Name: Lesogaberan

Documents available

CSR-D9120C00022.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles AB Phase I services Quintiles AB Phase I services, Uppsala Sweden

+ 46 (0)18 431 1000

[email protected]

Investigators

Principal Investigator

Wolfgang Kuhn

Quintiles AB, Phase I Services, Strandbodgatan 1, 753 23 Uppsala, Sweden