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NCT00652795

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

Completed Phase 1 Last updated 1 April 2008
What this trial tests

Phase 1 trial testing Doxycycline Monohydrate in To Determine Bioequivalence Under Fasting Conditions in 36 participants. Completed in 1 September 2004.

Timeline
1 July 2004
Primary endpoint
1 September 2004
1 September 2004

Quick facts

Lead sponsorPar Pharmaceutical, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Enrollment36
Start date1 July 2004
Primary completion1 September 2004
Estimated completion1 September 2004
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Par Pharmaceutical, Inc. — full company profile →

Who can join

18 and older, any sex, with To Determine Bioequivalence Under Fasting Conditions. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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