Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
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ClinicalTrials.gov Identifier: NCT00649870 |
Recruitment Status
:
Completed
First Posted
: April 1, 2008
Last Update Posted
: November 25, 2009
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Sponsor:
Mylan Pharmaceuticals
Information provided by:
Mylan Pharmaceuticals
Tracking Information | ||||
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First Submitted Date ICMJE | March 30, 2008 | |||
First Posted Date ICMJE | April 1, 2008 | |||
Last Update Posted Date | November 25, 2009 | |||
Study Start Date ICMJE | May 2005 | |||
Actual Primary Completion Date | May 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [ Time Frame: blood collections through 24 hours ] | |||
Original Primary Outcome Measures ICMJE |
Bioequivalence [ Time Frame: within 30 days ] | |||
Change History | Complete list of historical versions of study NCT00649870 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg | |||
Official Title ICMJE | Single-Dose Food In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers | |||
Brief Summary | The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
26 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | June 2005 | |||
Actual Primary Completion Date | May 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00649870 | |||
Other Study ID Numbers ICMJE | VALA-0405 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Wayne Talton, Mylan Inc. | |||
Study Sponsor ICMJE | Mylan Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mylan Pharmaceuticals | |||
Verification Date | November 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |