Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder
Completed
UCB Pharma
Phase 4
2005-10-01
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in
symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective
Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI)
to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at
least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder.
Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI
alone during the study. Most symptom evaluations will be done using an automated phone
interview system. There are 4 clinic visits.
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions
Completed
Actavis Inc.
Phase 1
2006-06-01
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 fasting conditions.
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions
Completed
Actavis Inc.
Phase 1
2006-07-01
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.
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