Drug Interaction Study Between AZD3355 and Nexium

Gastroesophageal Reflux Disease Clinical Trial

Official title:

An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684190
• Other study ID #: D9120C00016
• Secondary ID: EudraCt nr 2007-
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2008
• Last updated: December 2, 2010
• Start date: March 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 evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• 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

• Females no childbearing potential

• 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 Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• AZD3355
150 mg bid, oral, 7 days
• Esomeprazole
40 mg od, oral, 7 days

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during day 7 each treatment period	No
Secondary	4-BOH cholesterol		Sampling occasions during day 7 one treatment period (AZD3355 alone)	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment period	Yes