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Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01321502
First received: March 21, 2011
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

Drug Information available for: Famciclovir
U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321502

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

No publications provided

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
Study First Received: March 21, 2011
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Roxane Laboratories:
treatment of herpes

Additional relevant MeSH terms:
Famciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013