NCT01222897

A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioequivalence Study Comparing Valacyclovir Hydrochloride Tablets 1 Gram of Ohm Laboratories Inc. (A Subsidiary of Ranbaxy Pharmaceuticals Inc., USA) With VALTREX® Caplets 1 Gram (Containing Valacyclovir Hydrochloride 1 Gram) of GlaxoSmithKline in Healthy, Adult, Male, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX® caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy, adult, male, human subjects under fed condition.

Detailed description

Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of Valacyclovir hydrochloride 1 gram of either test or reference investigational product was administered during each period of the study (on day 01 and 04), along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. Both test and reference products were administered to all the study subjects, one in each period (except subject number 14 who dropped out from the study and subject number 37 who was withdrawn from the study). During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Valacyclovir hydrochloride

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2010-10-18
• Last updated: 2010-10-18

Locations

1 site across 1 country: India