Famciclovir 500 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834431
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Famciclovir 500 mg Tablets
Drug: Famvir® 500 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax = Maximum Observed Concentration. [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [ Time Frame: Blood samples collected over a 16 hour period. ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Famciclovir 500 mg Tablets
1 x 500 mg, single-dose fasting
Active Comparator: 2 Drug: Famvir® 500 mg Tablets
1 x 500 mg, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834431

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Canada, Ontario
Ba Research Co.
Toronto, Ontario, Canada, M1P2X4
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Irwin Plisco, M.D. Cetero Research, San Antonio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00834431     History of Changes
Other Study ID Numbers: B044501
Study First Received: January 30, 2009
Results First Received: June 30, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Famciclovir
2-Aminopurine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014