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Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01321515
First received: March 21, 2011
Last updated: March 22, 2011
Last verified: March 2011

March 21, 2011
March 22, 2011
July 2007
July 2007   (final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01321515 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fasting Conditions

The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fasting conditions.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Herpes Nos
Drug: famciclovir
500 mg tablet
Other Name: FAMVIR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to famciclovir, penciclovir or any comparable or similar product.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01321515
FAMC-T500-PVFS-1
No
Elizabeth Ernst, Executive Director, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Benno G Roesch, M.D. Advanced Biomedical Research
Roxane Laboratories
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP