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”

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • AZD3355 150 mg
• Experimental: 2
  • Esomeprazole 40mg
• Experimental: 3
  • AZD3355 150mg/Esomeprazole 40mg

Primary Measures

• PK variables
  • Time Frame: Frequent sampling occasions during day 7 each treatment period
    Safety Issue?: No

Secondary Measures

• 4-BOH cholesterol
  • Time Frame: Sampling occasions during day 7 one treatment period (AZD3355 alone)
    Safety Issue?: No
• Safety variables (adverse events, blood pressure, pulse, safety lab)
  • Time Frame: During the whole treatment period
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Eva Ersdal, PhD Study Director AstraZeneca R&D, Mölndal, Sweden  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00684190

Study ID Number: D9120C00016

ClinicalTrials.gov Identifier: NCT00684190

Health Authority: Sweden: Medical Products Agency