Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions

Roxane Laboratories48 enrolled

Overview

The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Herpes Zoster Shingles Genital Herpes

Interventions

Valacyclovir HydrochlorideDRUG

1000 mg caplet

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 valacyclovir hydrochloride or any comparable or similar product.

Locations (1)

PRACs Institute, Ltd.

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 8 days

Data from ClinicalTrials.gov

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