NCT01380496

Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions

Randomized, 3-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 and Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 fed and fasting conditions.

Conditions

• To Determine Bioequivalence Under Fed Conditions

Interventions

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

Timeline

• Start date: 1999-11-01
• Primary completion: 1999-11-01
• Completion: 1999-11-01
• First posted: 2011-06-27
• Last updated: 2017-09-26

Locations

1 site across 1 country: Canada