Study to Compare Different Formulations of AZD3355

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688402
• Other study ID #: D9120C00031
• Secondary ID: EudraCT nr 2007-
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2008
• Last updated: December 2, 2010
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of written informed consent

• Female subjects with no childbearing potentials or using highly efficient contraceptive methods

• Clinically normal physical findings

Exclusion Criteria:

• Clinically significant illness within 2 weeks prior to the first dose of investigational product

• History of clinically significant disease

• Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• AZD3355
Single dose

Locations

Country	Name	City	State
Sweden	Research Site	Varvsgatan	Lulea

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific AE questions		During 0-4 hours post dose	Yes
Secondary	PK variables		Frequent sampling up to 36 hours post dose	No
Secondary	Safety variables (other adverse events, blood pressure, pulse, safety lab)		During the whole treatment period	Yes