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Trial record 50 of 371 for:    under | North Dakota, United States

Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT01132716
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : January 23, 2018
Sponsor:
Information provided by:
West-Ward Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Herpes Zoster Shingles Genital Herpes Drug: Valacyclovir Hydrochloride Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fed Conditions
Study Start Date : September 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition


Intervention Details:
  • Drug: Valacyclovir Hydrochloride
    1000 mg caplet
    Other Name: Valtrex


Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132716


Locations
United States, North Dakota
PRACs Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Alan Copa, PharmD PRACs Institute, Ltd.

Responsible Party: Elizabeth Ernst, Cirector, Drug Regulatory and Medical Affairs, Roxane Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT01132716     History of Changes
Other Study ID Numbers: VALA-T1000-PVFD-1
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Herpes Zoster
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Herpes Simplex
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents