NCT01380483

Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

Randomized, 2-way Crossover, Comparative Bioequivalence Study of Par Pharmaceutical Inc. (USA) and Oclassen Pharmaceuticals Inc. (USA) (Monodox(R)) Doxycycline Monohydrate Equivalent to 100 mg Doxycycline Administered as a Single Dose of 100 mg In Healthy Adult Males Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate, 100 mg.

Detailed description

To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fasting conditions.

Conditions

• To Determine Bioequivalence Under Fasting Conditions

Interventions

Type	Name	Description
DRUG	doxycycline monohydrate	Tablets, 100 mg, single, oral dose
DRUG	doxycycline monohydrate	Capsule, 100 mg, single, oral dose

Timeline

• Start date: 2000-01-01
• Primary completion: 2000-04-01
• Completion: 2000-04-01
• First posted: 2011-06-27
• Last updated: 2011-06-27

Locations

1 site across 1 country: Canada