Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions

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

Completed

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Key information

Conditions

Herpes Zoster Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Herpes Herpes Genitalis Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Shingles Urogenital Diseases Varicella Zoster Virus Infection Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PRACs Institute, Ltd.

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valacyclovir Hydrochloride

Drug

1000 mg caplet

Other names: Valtrex

Primary outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fed Conditions

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: May 28, 2010
Registry last updated: Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed