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Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

2014-08-27 03:24:40 | BioPortfolio

Summary

The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle & Co.) in healthy, adult, non-smoking subjects under non-fasting conditions.

Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Healthy

Intervention

Zolpidem 10 mg tablets, AMBIEN® 10 mg tablets

Location

Novum Pharmaceutical Research Services
Pittsburgh
Pennsylvania
United States
15206

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:40-0400

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Medical and Biotech [MESH] Definitions

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

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.

A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.

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)

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.

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