Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
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.
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
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Veeda clinical research Pvt. Ltd., India
Dr. Reddy's Laboratories Limited
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01136525
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
4(1-Naphthylvinyl)pyridine hydrochloride. Cholinesterase inhibitor. Synonym: YuB 25.
Used in the form of the hydrochloride as a reagent in ANALYTICAL CHEMISTRY TECHNIQUES.
A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.
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.
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.
The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.
The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.
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