Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition

Sponsor
Dr. Reddy's Laboratories Limited
Study ID
NCT01136538
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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 fed conditions. 2. monitor the adverse events and ensure the safety of subjects.

Key Dates

Start date
Feb 28, 2007
Status verified
Jun 2010
Primary completion
Feb 28, 2007
Completion
May 31, 2007

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Valacyclovir Hydrochloride
    Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
  • Active Comparator: Valtrex (R)
    Valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline

Primary Outcome Measure

Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ]

Related Studies