Prilosec Bioequivalence Study in Healthy Volunteers
Completed · Phase 1
Conditions studied: Bioequivalence, AUC, Cmax, Pharmacokinetics
In brief
This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck
Key facts
- Study ID
- NCT01921920
- Run by
- AstraZeneca
- People needed
- 54
- Starts
- 2013-08-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2013-11-25
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female volunteers aged 18 to 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture.
- Female could be of nonchildbearing potential (postmenopausal or irreversible surgical sterilization) and childbearing potential (negative pregnancy test at screening and use 2 effective methods of avoiding pregnancy).
- Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and a weight of at least 50 kg and no more than 100 kg, inclusive.
You may not qualify if…
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
- Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
- Moderate to heavy smokers (more than 10 cigarettes per day or equivalent in tobacco-containing products).
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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