Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions

Part of paid clinical trials in Fargo, North Dakota.

Sponsor
Roxane Laboratories
Study ID
NCT01132716
Status
Completed

Conditions

  • Genital Herpes
  • Herpes Zoster
  • Shingles

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.

Key Dates

Start date
Sep 30, 2006
Status verified
Jan 2018
Primary completion
Sep 30, 2006
Completion
Sep 30, 2006

Study Design

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

Primary Outcome Measure

bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRACs Institute, Ltd.FargoNorth Dakota58104-

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PRACs Institute, Ltd.· Fargo, ND

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