Trial Profile

A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fasting Conditions.

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 10 Jul 2010

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At a glance

Drugs Valaciclovir (Primary)
Indications Cytomegalovirus infections; Herpes simplex virus infections; Herpes zoster; Herpesvirus infections
Focus Pharmacokinetics

Most Recent Events

09 Jun 2010 According to a Roxane Laboratories Inc media release, the US Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) of Valacyclovir Hydrochloride Tablets 500mg and 1g.
01 Jun 2010 New trial record

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