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Completed

NCT Number: NCT00684190

Drug Interaction Study Between AZD3355 and Nexium

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD3355

Drug

150 mg bid, oral, 7 days

Other names: Lesogaberan

Esomeprazole

Drug

40 mg od, oral, 7 days

Other names: Nexium

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during day 7 each treatment period

Secondary outcomes

  1. 4-BOH cholesterol

    Time frame: Sampling occasions during day 7 one treatment period (AZD3355 alone)

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

    Time frame: During the whole treatment period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 26, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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