Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions

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


The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. following an overnight fast of at least 10 hours.


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




Doxycycline Monohydrate, Doxycycline Monohydrate


CEDRA Clinical Research
San Antonio
United States




Teva Pharmaceuticals USA

Results (where available)

View Results


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

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