Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• To Determine Bioequivalence Under Fasting Conditions

• NCT number: NCT00653380
• Study type: Interventional
• Source: Par Pharmaceutical, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: September 1999
• Completion date: October 1999