Drug Interaction Study Between AZD3355 and Nexium - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: AZD3355 Drug: Esomeprazole	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PK variables [ Time Frame: Frequent sampling occasions during day 7 each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	30
Study Start Date:	March 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD3355 150 mg	Drug: AZD3355 150 mg bid, oral, 7 days Other Name: Lesogaberan
Experimental: 2 Esomeprazole 40mg	Drug: Esomeprazole 40 mg od, oral, 7 days Other Name: Nexium
Experimental: 3 AZD3355 150mg/Esomeprazole 40mg	Drug: AZD3355 150 mg bid, oral, 7 days Other Name: Lesogaberan Drug: Esomeprazole 40 mg od, oral, 7 days Other Name: Nexium

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684190

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Eva Ersdal, PhD	AstraZeneca R&D, Mölndal, Sweden
Principal Investigator:	Jan Vouis, MD	Quintiles AB, Uppsala, Sweden

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51.

Responsible Party:	Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00684190 History of Changes
Other Study ID Numbers:	D9120C00016, EudraCt nr 2007-007128-16
Study First Received:	May 22, 2008
Last Updated:	December 2, 2010
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Reflux Inhibitor
GERD
PPI Interaction

Additional relevant MeSH terms:

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

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013