Study to Compare different formulations of AZD3355

Study identifier:D9120C00031

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A double-blind, randomized, cross-over design, phase 1 pharmacodynamic study to investigate the effect of different formulations of AZD3355 for the development of paresthesiae after dosing in healthy subjects

Medical condition

Gastroesophageal Reflux Disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3355

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Apr 2008

Primary Completion Date: 01 Jun 2008

Study Completion Date: 01 Jun 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Varvsgatan, Lulea, Sweden

Arms	Assigned Interventions
Experimental: 1 IR Formulation 65 mg	Drug: AZD3355 Single dose Other Name: Lesogaberan
Experimental: 2 IR Formulation 150 mg	Drug: AZD3355 Single dose Other Name: Lesogaberan
Experimental: 3 MR formulation, 1h 65 mg	Drug: AZD3355 Single dose Other Name: Lesogaberan
Experimental: 4 MR Formulation, 1h 150 mg	Drug: AZD3355 Single dose Other Name: Lesogaberan
Experimental: 5 MR Formulation, 2h 150 mg	Drug: AZD3355 Single dose Other Name: Lesogaberan

Documents available

CSR-D9120C00031.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Eva Ersdal

AstraZeneca R&d, Mölndal, Sweden