Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834431 |
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 I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Fasting Conditions |
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 |
---|---|
1: Experimental |
Drug: Famciclovir 500 mg Tablets
1 x 500 mg, single-dose fasting
|
2: Active Comparator |
Drug: Famvir® 500 mg Tablets
1 x 500 mg, single-dose fasting
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Clinical laboratory measurements will include the following:
Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Exclusion Criteria:
United States, Missouri | |
Gateway Medical Research, Inc. | |
St. Charles, Missouri, United States, 63301 | |
Canada, Ontario | |
Ba Research Co. | |
Toronto, Ontario, Canada, M1P2X4 |
Principal Investigator: | Irwin Plisco, M.D. | Cetero Research |
Study ID Numbers: | B044501 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00834431 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Antimetabolites Famciclovir 2-Aminopurine Healthy Antiviral Agents |
Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Famciclovir |
Therapeutic Uses 2-Aminopurine Antiviral Agents Pharmacologic Actions |