Valacyclovir 1000 mg Tablet Under Fasting Conditions

Part of paid clinical trials in East Grand Forks, Minnesota.

Sponsor
Teva Pharmaceuticals USA
Study ID
NCT01149499
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 is to compare the rate and extent of absorption of valacyclovir 1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under fasting conditions.

Key Dates

Start date
Jan 31, 2005
Status verified
Jun 2010
Primary completion
Jan 31, 2005
Completion
Jan 31, 2005

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: Valacyclovir
    Test 1000 mg Valacyclovir Tablet
  • Active Comparator: Valtrex
    Reference Listed 1000 mg Valtrex Tablet

Primary Outcome Measure

Cmax (maximum observed concentration of drug substance in plasma) [ Time Frame: Blood samples collected over 16 hour period ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRACS Institute, Ltd.East Grand ForksMinnesota56721-

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PRACS Institute, Ltd.· East Grand Forks, MN

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