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Gastro-focused pharmaceutical company begins clinical trials for antacid capsules

Published in Medical Letter on the CDC and FDA, September 26th, 2004

Santarus, Inc. (SNTS), a pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, has initiated a pivotal pharmacokinetic/pharmacodynamic (PK/PD) clinical trial to evaluate Zegerid 40 mg capsules, an immediate-release formulation of the proton pump inhibitor (PPI) omeprazole.

The primary objective of this newly initiated clinical trial is to evaluate whether the 40 mg immediate-release Zegerid (omeprazole) capsules are pharmacokinetically equivalent to 40 mg delayed-release omeprazole capsules with respect to total systemic bioavailability.

The trial will also assess whether Zegerid capsules and the delayed-release...

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