Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

This study has been completed.

Sponsor:

Information provided by:

Roxane Laboratories

ClinicalTrials.gov Identifier:

NCT01321515

First received: March 21, 2011

Last updated: March 22, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2011

Last Updated Date

March 22, 2011

Start Date ^ICMJE

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01321515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bioequivalency Study of Famciclovir 500 mg Tablets Under Fasted Conditions

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Herpes Nos

Intervention ^ICMJE

Drug: famciclovir

500 mg tablet

Other Name: FAMVIR

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01321515

Other Study ID Numbers ^ICMJE

FAMC-T500-PVFS-1

Has Data Monitoring Committee

Responsible Party

Elizabeth Ernst, Executive Director, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Benno G Roesch, M.D.

Advanced Biomedical Research

Information Provided By

Roxane Laboratories

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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