Drug Interaction Study Between AZD3355 and Nexium

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: AZD3355 (Drug); Esomeprazole (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Eva Ersdal, PhD, Study Director, Affiliation: AstraZeneca R&D, Mölndal, Sweden
Jan Vouis, MD, Principal Investigator, Affiliation: Quintiles AB, Uppsala, Sweden

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.

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

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

Primary outcome: PK variables

Secondary outcome:

4-BOH cholesterol

Safety variables (adverse events, blood pressure, pulse, safety lab)

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Research Site, Uppsala, Sweden

Starting date: March 2008
Ending date: August 2008
Last updated: May 23, 2008