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Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions

2014-08-27 03:24:51 | BioPortfolio

Summary

The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate hydrochloride in a test population of 24 adult subjects under fasted 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

Dexmethylphenidate Hydrochloride, Dexmethylphenidate Hydrochloride

Location

Gateway Medical Research, Inc.
St. Charles
Missouri
United States
63301

Status

Completed

Source

Teva Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:51-0400

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