NCT00652795

Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions

Randomized, 2-Way Crossover, Bioequivalence Study of Doxycycline 150 mg Tablet and Monodox 50 mg Capsule Administered as 1 x 150 mg Tablet or 3 x 50 mg Capsules in Healthy Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).

Detailed description

To compare the rate and extent of absorption of doxycycline 150 mg tablet (test) versus Monodox 50 mg capsule (reference) administered as 1 x 50 mg tablet or 3 x 50 mg capsules under fasting conditions.

Conditions

• To Determine Bioequivalence Under Fasting Conditions

Interventions

Type	Name	Description
DRUG	Doxycycline Monohydrate	Tablets, 150 mg, single-dose
DRUG	Monodox	Capsules 50 mg (3 x 50 mg dose), single-dose

Timeline

• Start date: 2004-07-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2008-04-04
• Last updated: 2008-04-04

Locations

1 site across 1 country: Canada