Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions

Herpes Clinical Trial

Official title:

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Famciclovir Tablets Under Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321502
• Other study ID #: FAMC-T500-PVFD-1
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: January 19, 2018
• Start date: July 2007
• Est. completion date: July 2007

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes

Intervention

Drug:
• famciclovir
500 mg tablet

Locations

Country	Name	City	State
United States	Advanced Biomedical Research	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence determined by statistical comparison Cmax		8 days