A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Non-fasting Conditions

NCT01188057 Phase 1 COMPLETED

This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under non-fasting conditions.

Details

Lead sponsor	Actavis Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	40
Start date	2006-07
Completion	2006-08

Conditions

• Healthy

Interventions

• ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG
• NIRAVAM TM 2 mg orally disintegrating tablets, single dose

Primary outcomes

• Rate and Extend of Absorption — 72hr

Countries

United States