Famciclovir 500 mg Tablets Under Non-Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00834444
• Date of registration: 30/01/2009
• Primary sponsor: Teva Pharmaceuticals USA
• Public title: Famciclovir 500 mg Tablets Under Non-Fasting Conditions
• Scientific title: A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Non-Fasting Conditions
• Date of first enrolment: August 2004
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00834444
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

Canada, United States

Contacts

• Name: Irwin Plisco, M.D.
• Affiliation: Cetero Research, San Antonio

Key inclusion & exclusion criteria

Inclusion Criteria:

- All subjects selected for this study will be at least 18 years of age.

- Each subject shall be given a general physical examination within 28 days of
initiation of the study. Such examination includes, but is not limited to, blood
pressure, general observations, and history.

- Each female subject will be give a serum pregnancy test as part of the pre-screening
process.

- Adequate blood and urine samples should be obtained within 28 days before beginning
of the first period and at the end of the trial for clinical laboratory measurements.

Clinical laboratory measurements will include the following:

- Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood
cell count (with differential).

- Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and
alkaline phosphatase.

- Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult
blood, and cells.

- HIV Screen: pre-study only.

- Hepatitis-B, C Screen: pre-study only.

- Drugs of Abuse Screen: pre-study and at check-in each study period.

Electrocardiograms of all participating subjects will be recorded before initiation of the
study and filed with each subject's case report forms.

Exclusion Criteria:

- Subjects with a history of alcoholism or drug addiction (during past 2 years), or
serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis,
epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be
eligible for this study.

- Subjects whose clinical laboratory test values are outside the normal range may be
retested at the discretion of the clinical investigator. If the clinical values are
outside the range on retesting, the subject will not be eligible to participate in
the study unless the clinical investigator deems the result to not be significant.

- Subjects who have a history of allergic responses to the class of drug being tested
should be excluded form the study.

- All subjects will have urine samples assayed for the presence of drugs of abuse as
part of the clinical laboratory screening procedures and at each check-in. Subjects
found to have urine concentrations of any of the tested drugs will not be allowed to
participate.

- Subjects should not have donated blood and/or plasma for at least thirty (30) days
prior to the first dosing of the study.

Subjects who have taken any investigational drug within thirty (30) days prior to the
first dosing of the study will not be allowed to participate.

- Female subjects who are pregnant, breast-feeding, or who are likely to become
pregnant during the study will not be allowed to participate. Female subjects of
child bearing potential must either abstain from sexual intercourse or use a reliable
barrier method (e.g. condom, IUD) of contraception during the course of the study
(first dosing until last blood collection) or they will not be allowed to
participate. Subjects who have used implanted or injected hormonal contraceptives
anytime during the 6 months prior to study dosing, or used oral hormonal
contraceptives within 14 days before dosing will not be allowed to participate.

- All female subjects will be screened for pregnancy at check-in each study period.
Subjects with positive or inconclusive results will be withdrawn from the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Famciclovir 500 mg Tablets

Drug: Famvir® 500 mg Tablets

Primary Outcome(s)

AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [Time Frame: Blood samples collected over a 16 hour period.]

AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) [Time Frame: Blood samples collected over a 16 hour period.]

Cmax = Maximum Observed Concentration. [Time Frame: Blood samples collected over a 16 hour period.]

Secondary ID(s)

B044502

Source(s) of Monetary Support

Please refer to primary and secondary sponsors