NCT01321502

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

March 21, 2011

Last Update Submit

January 19, 2018

Conditions

Herpes

Keywords

treatment of herpes

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    8 days

Interventions

famciclovirDRUG

500 mg tablet

Also known as: Famvir

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Biomedical Research

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

Famciclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 23, 2011

Study Start

July 1, 2007

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)