Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions

13:53 EDT 23rd October 2014 | BioPortfolio

Summary

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)

Description

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline by Par Pharmaceutical Inc., USA (test) versus Monodox by Oclassen Pharmaceuticals, Inc., USA (reference) administered as a 1 x 100 mg capsule under fasting and fed conditions.

Study Design

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

Conditions

To Determine Bioequivalence Under Fed Conditions.

Intervention

Doxycycline monohydrate, Monodox, Doxycycline Monohydrate

Location

Anapharm, Inc.
Sainte-Foy
Quebec
Canada
G1V 2K8

Status

Completed

Source

Par Pharmaceutical, Inc.

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

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