Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA 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 subjects administered under fasting conditions.
Description
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Alprazolam Extended-Release 3 mg Tablets, Alprazolam Extended-Release 3 mg Tablets
Location
PRACS Institute, Ltd.
East Grand Forks
Minnesota
United States
56721
Status
Completed
Source
Teva Pharmaceuticals USA
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00829426
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Contact Lenses, Extended-wear
Hydrophilic contact lenses worn for an extended period or permanently.
Alprazolam
A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238)
Breech Presentation
A malpresentation of the FETUS at near term or during OBSTETRIC LABOR with the fetal cephalic pole in the fundus of the UTERUS. There are three types of breech: the complete breech with flexed hips and knees; the incomplete breech with one or both hips partially or fully extended; the frank breech with flexed hips and extended knees.
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
Clinical Trials
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA wi...
Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 3 mg Extended-release tablets to Pharmacia & Upjohn's Xanax XR® 3 mg tablets following a single, or...
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 Comp...
A Relative Bioavailability Study of Alprazolam 3 mg ER Tablets Under Fasting Conditions
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 Comp...
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and...
PubMed Articles
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Metoprolol succinate extended release tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery...
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We prepared and evaluated imperatorin (IMP) sustained-release tablets. IMP is an active compound in Angelica dahuricae, a Chinese herbal medicine. We used different polymers, such as hydroxypropyl met...
