Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg... | NCT00688428

Studies
Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

NCT00688428

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 12, 2009Estimated

Enrollment

84Estimated

Phase

Phase 1

Conditions

Ulcers
Upper GI Symptoms

Interventions

Esomeprazole 40mg/ASA 325mg
Esomeprazole
ASA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

Jun 2, 2008

First Posted Date

Jun 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2009

Last Update Posted Date

Mar 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	combination capsule of Esomeprazole 40mg + ASA 325mg	Drug: Esomeprazole 40mg/ASA 325mg
2	Experimental	Esomeprazole 40 mg capsule and ASA 325 mg tablet	Drug: Esomeprazole Drug: ASA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole 40mg/ASA 325mg	Drug	combination capsule, administered as a single oral dose	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Samples for measurement of esomeprazole, ASA, and SA concentrations		Day 1 of each period

Secondary Outcomes

Measure	Description	Time Frame
Fasting blood samples for determination of clinical chemistry and hematology parameters		screening and follow up visit
urine samples for urinalysis parameters		screening, Period 1, and follow-up visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index of 19-29kg/m2, inclusive
Weight of 50-95kg, inclusive
Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

Exclusion Criteria:

Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
Condition which could modify the absorption of the investigational products, as judged by the Investigator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jörgen Naesdal, M.D.	AstraZeneca	Study Director
Christopher Billings ., D.O	Biokinetics Clinical Applications	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014456	Ulcer

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064098	Esomeprazole
D001241	Aspirin

Ancestor Terms

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided