NCT00653380

Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions

Randomized, Open-Label, 2-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 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 of 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 conditions.

Conditions

• To Determine Bioequivalence Under Fasting Conditions

Interventions

Type	Name	Description
DRUG	Doxycycline Monohydrate	Capsules, 100 mg, single-dose
DRUG	Monodox	Capsules, 100 mg, single-dose

Timeline

• Start date: 1999-09-01
• Primary completion: 1999-10-01
• Completion: 1999-10-01
• First posted: 2008-04-04
• Last updated: 2008-04-04

Locations

1 site across 1 country: Canada