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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

Page last updated: August 23, 2015

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