NCT00652704

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

Randomized, Open-Label, 3-Way Crossover, Comparative Bioavailability Study of Par's and Oclassen's (Monodox) Doxycycline Monohydrate Capsules Administered as 1 x 100 mg Capsule 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

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

Detailed 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.

Conditions

• To Determine Bioequivalence Under Fed Conditions

Interventions

Type	Name	Description
DRUG	Doxycycline monohydrate	Capsules, 100 mg, fed
DRUG	Monodox	Capsules, 100 mg, fed
DRUG	Doxycycline Monohydrate	Capsules, 100 mg, fasting

Timeline

• Start date: 1999-07-01
• Primary completion: 1999-09-01
• Completion: 1999-09-01
• First posted: 2008-04-04
• Last updated: 2017-09-26

Locations

1 site across 1 country: Canada