Back to resultsBioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
Primary Purpose
Herpes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
famciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Herpes focused on measuring treatment of herpes
Eligibility 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.
Sites / Locations
- Advanced Biomedical Research
Outcomes
Primary Outcome Measures
bioequivalence determined by statistical comparison Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01321502
Brief Title
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
Official Title
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Famciclovir 500 mg Tablets under fed conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes
Keywords
treatment of herpes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
famciclovir
Other Intervention Name(s)
Famvir
Intervention Description
500 mg tablet
Primary Outcome Measure Information:
Title
bioequivalence determined by statistical comparison Cmax
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Advanced Biomedical Research
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions
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