Bioequivalency Study of Famciclovir 500 mg Tablets Under Fed Conditions

N/ACompletedNCT01321502

Roxane Laboratories31 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Herpes

Interventions

famciclovirDRUG

500 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Advanced Biomedical Research

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 8 days

Data from ClinicalTrials.gov

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