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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01321515
Other study ID # FAMC-T500-PVFS-1
Secondary ID
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
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 36
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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
famciclovir
500 mg tablet

Locations

Country Name City State
United States Advanced Biomedical Research, Inc. 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
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