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| Sponsor: | Actavis Inc. |
|---|---|
| Information provided by: | Actavis Inc. |
| ClinicalTrials.gov Identifier: | NCT00865657 |
Purpose
The purpose of this study is to compare the relative bioavailability of 3 mg Alprazolam Extended Release Tablets by Alpharma with that of 3 mg XANAX XR® Tablets by Pharmacia & Upjohn Company following a single oral dose (1 x 3 mg extended-release tablet) in healthy adult volunteers administrated under non-fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Alprazolam 3 mg Extended Release Tablets, single dose Drug: XANAX XR® 3 mg tablets, single dose |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Non-Fasting Conditions |
| Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Alprazolam 3 mg Extended Release Tablets, single dose
|
Drug: Alprazolam 3 mg Extended Release Tablets, single dose
A: Experimental Subjects received Alpharma formulated products under non-fasting conditions
Other Name: Alprazolam
|
|
Active Comparator: B
XANAX XR® 3 mg tablets, single dose
|
Drug: XANAX XR® 3 mg tablets, single dose
B: Active comparator Subjects received Pharmacia & Upjohn Company formulated products under non-fasting conditions
Other Name: Alprazolam
|
Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover study under non-fasting conditions.
Official Title: A Relative Bioavailability Study of 3 mg Alprazolam Extended Release Tablets Under Non-Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The screening clinical laboratory procedures will include:
If female and:
Exclusion Criteria:
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58102 | |
| Principal Investigator: | James D. Carlson,, Pharm.D, | PRACS Institute, Ltd. |
More Information
| Responsible Party: | Meena Venugopal, Director, Clinical R&D, Actavis Inc |
| ClinicalTrials.gov Identifier: | NCT00865657 History of Changes |
| Other Study ID Numbers: | R05-0852 |
| Study First Received: | March 18, 2009 |
| Last Updated: | August 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Bioequivalence Alprazolam Healthy subjects |
|
Alprazolam Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |