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

Sponsor
Ranbaxy Laboratories Limited
Study ID
NCT01222910
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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 fasting condition.

Key Dates

Start date
May 31, 2009
Status verified
Oct 2010
Primary completion
May 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: Test
    Valacyclovir hydrochloride tablets 1 gm of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceuticals Inc.)
  • Active Comparator: Reference
    VALTREX® (valacyclovir HCl) caplets 1 gm of GlaxoSmithKline Research Triangle Park, NC 27709

Primary Outcome Measure

Bioequivalence evaluation of Valacyclovir Hydrochloride tablets 1gm under fasting conditions

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