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Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321515
First Posted: March 23, 2011
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Roxane Laboratories
March 21, 2011
March 23, 2011
March 23, 2011
July 2007
July 2007   (Final data collection date for primary outcome measure)
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01321515
FAMC-T500-PVFS-1
No
Not Provided
Not Provided
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