Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg
Summary
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, oral 3 mg (1 x 3 mg) dose administered under fasting conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Alprazolam Extended-Release Tablets 3 mg, Xanax XR® Tablets (3 mg
Location
Kendle International Inc.
Morgantown
West Virginia
United States
26505
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00647634
- 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)
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.
Tablets
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Excipients
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
Clinical Trials
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under 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...
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...
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...
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.
PubMed Articles
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