Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
Mylan Pharmaceuticals Inc
Study ID
NCT00649974
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.

Key Dates

Start date
May 31, 2005
Status verified
Apr 2024
Primary completion
May 31, 2005
Completion
May 31, 2005

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: 1
    Valacyclovir Hydrochloride Tablets 1000 mg
  • Active Comparator: 2
    Valtrex® Tablets 1000 mg

Primary Outcome Measure

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. [ Time Frame: blood collections through 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kendle International Inc.MorgantownWest Virginia26505-

Find similar trials in Morgantown, WV

By research site
Kendle International Inc.· Morgantown, WV

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