DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcers; Upper GI Symptoms

Intervention: Esomeprazole 40mg/ASA 325mg (Drug); Esomeprazole (Drug); ASA (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Jörgen Naesdal, M.D., Study Director, Affiliation: AstraZeneca
Christopher Billings ., D.O, Principal Investigator, Affiliation: Biokinetics Clinical Applications

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Samples for measurement of esomeprazole, ASA, and SA concentrations

Secondary outcome:

Fasting blood samples for determination of clinical chemistry and hematology parameters

urine samples for urinalysis parameters

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: April 2008
Last updated: March 11, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017