Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster; Shingles; Genital Herpes
Intervention: Valacyclovir Hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s): Alan Copa, PharmD, Principal Investigator, Affiliation: PRACs Institute, Ltd.
Summary
The objective of this study was to prove the bioequivalence of Valacyclovir
Hydrochlorothiazide Caplet under fasting conditions.
Clinical Details
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: bioequivalence determined by statistical comparison Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
PRACs Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information
Starting date: September 2006
Last updated: October 6, 2010
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