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Tracking Information | |||||
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First Received Date ICMJE | March 30, 2008 | ||||
Last Updated Date | March 31, 2008 | ||||
Start Date ICMJE | November 2002 | ||||
Primary Completion Date | December 2002 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00649857 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg | ||||
Official Title ICMJE | Single-Dose Food In Vivo Bioequivalence Study of Cetirizine HCl Tablets (10 mg; Mylan) and Zyrtec® (10 mg; Pfizer) in Healthy Volunteers | ||||
Brief Summary | The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed conditions. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 18 | ||||
Completion Date | December 2002 | ||||
Primary Completion Date | December 2002 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00649857 | ||||
Other Study ID Numbers ICMJE | CETI-0287 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. | ||||
Study Sponsor ICMJE | Mylan Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Mylan Pharmaceuticals | ||||
Verification Date | March 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |