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Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321502
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
  Purpose
The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fed conditions.

Condition Intervention
Herpes Nos Drug: famciclovir

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]

Enrollment: 31
Study Start Date: July 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: famciclovir
    500 mg tablet
    Other Name: Famvir
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321502


Locations
United States, New Jersey
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Roxane Laboratories
  More Information

Responsible Party: Elizabeth Ernst, Executive Director, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01321502     History of Changes
Other Study ID Numbers: FAMC-T500-PVFD-1
First Submitted: March 21, 2011
First Posted: March 23, 2011
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Roxane Laboratories:
treatment of herpes

Additional relevant MeSH terms:
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action