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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00829764 |
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. following an overnight fast of at least 10 hours.
Condition | Intervention | Phase |
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Healthy |
Drug: Doxycycline Monohydrate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study of Doxycycline Monohydrate 25 mg as a 5 mL Oral Suspension Under Fasting Conditions |
Enrollment: | 30 |
Study Start Date: | October 2006 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Doxycycline Monohydrate
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Drug: Doxycycline Monohydrate
25 mg 5 mL dose
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2: Active Comparator
Vibramycin Monohydrate®
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Drug: Doxycycline Monohydrate
25 mg 5 mL dose
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Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
All subjects must satisfy the following criteria to be considered for study participation:
Exclusion Criteria
Subjects may be excluded for any of the following:
Study ID Numbers: | 20-064-SA |
Study First Received: | January 26, 2009 |
Results First Received: | June 30, 2009 |
Last Updated: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00829764 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Healthy Doxycycline |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Therapeutic Uses Pharmacologic Actions Doxycycline |