Prilosec Bioequivalence Study in Healthy Volunteers
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 11/23/2013 |
Start Date: | August 2013 |
End Date: | November 2013 |
Contact: | Quintiles Overland Park, Volunteer Recruitment Quintiles Overland Park, Volunteer Recruitment |
Phone: | +1 (913) 894-5533 |
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
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
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
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