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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. Anapharm |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00652795 |
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
Condition | Intervention | Phase |
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To Determine Bioequivalence Under Fasting Conditions |
Drug: Doxycycline Monohydrate Drug: Monodox |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | 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 |
Enrollment: | 36 |
Study Start Date: | July 2004 |
Study Completion Date: | September 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions.
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Drug: Doxycycline Monohydrate
Tablets, 150 mg, single-dose
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B: Active Comparator
Subjects received the Oclassen's product (Monodox) Capsules under fasting conditions.
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Drug: Monodox
Capsules 50 mg (3 x 50 mg dose), single-dose
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Par Pharmaceutical, Inc. ( Alfred Elvin/Director of Biopharmaceutics ) |
Study ID Numbers: | 40074 |
Study First Received: | April 1, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00652795 |
Health Authority: | United States: Food and Drug Administration |
bioequivalence doxycycline monohydrate fasting |
Healthy Doxycycline |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Therapeutic Uses Pharmacologic Actions |