Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
Summary
The purpose of this study is to
1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of GlaxoSmithkline, in healthy, adult human subjects under fasting conditions.
2. monitor the adverse events and ensure the safety of subjects.
Description
An open label, balanced, randomized, two-treatment, two-sequence two-period, single-dose, crossover comparative bioavailability study of 1000 mg Valacyclovir Hydrochloride Tablets of Dr. Reddy's Laboratories Ltd., India and valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline in healthy, adult human subjects under fasting conditions
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
Valacyclovir Hydrochloride
Location
Veeda clinical research Pvt. Ltd., India
Ahmedabad
Gujrat
India
380 015
Status
Completed
Source
Dr. Reddy's Laboratories Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01136525
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Naphthylvinylpyridine
4(1-Naphthylvinyl)pyridine hydrochloride. Cholinesterase inhibitor. Synonym: YuB 25.
Tetramethylphenylenediamine
Used in the form of the hydrochloride as a reagent in ANALYTICAL CHEMISTRY TECHNIQUES.
Ambroxol
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
Bupropion
A unicyclic, aminoketone antidepressant. The mechanism of its therapeutic actions is not well understood, but it does appear to block dopamine uptake. The hydrochloride is available as an aid to smoking cessation treatment.
Mechlorethamine
A vesicant and necrotizing irritant destructive to mucous membranes. It was formerly used as a war gas. The hydrochloride is used as an antineoplastic in Hodgkin's disease and lymphomas. It causes severe gastrointestinal and bone marrow damage.
Clinical Trials
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.
Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition
The purpose of this study is to 1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydroch...
To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or...
Valacyclovir 1000 mg Tablet Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1...
PubMed Articles
PURPOSE: To describe 3 cases of an acute zonal occult outer retinopathy-like illness responsive to valacyclovir hydrochloride. DESIGN: Retrospective, interventional case series. METHODS: Three patient...
A new simple, sensitive and precise liquid chromatography-tandem mass spectrometry method has been developed and validated for the determination of valacyclovir-HCl and acyclovir in tsetse flies (Glos...
Valacyclovir in the treatment of Acute Retinal Necrosis.
ABSTRACT: BACKGROUND: To report the outcome of oral valacyclovir as the sole antiviral therapy for patients with acute retinal necrosis (ARN). METHODS: This study reports a retrospective, intervention...
CONTEXT: Herpes simplex and herpes zoster infections are common and often treated with antiviral drugs including acyclovir, valacyclovir, and famciclovir. Safety of these antivirals when used in the f...
In this study, we investigated a simple, sensitive and reliable liquid chromatography-fluorescence detection method for the determination of memantine hydrochloride in rat plasma which was based on de...
