Fed 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
NCT00650494
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 GSK's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.

Key Dates

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

Study Design

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

Arms

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

Primary Outcome Measure

Bioequivalence [ Time Frame: within 30 days ]

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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