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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Upper GI Symptoms; Ulcers

Treatments: Drug: Esomeprazole 40mg/ASA 325mg; Drug: ASA; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688428

D961FC00002

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

1

Experimental group

Description:

combination capsule of Esomeprazole 40mg + ASA 325mg

Treatment:

Drug: Esomeprazole 40mg/ASA 325mg

2

Experimental group

Description:

Esomeprazole 40 mg capsule and ASA 325 mg tablet

Treatment:

Drug: Esomeprazole

Drug: ASA