Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions

Not Applicable

Completed

• Conditions: Herpes Zoster; Shingles; Genital Herpes

• Registration Number: NCT01132729
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	8 days

Trial Locations

Locations (1)

PRACs Institute, Ltd.; 🇺🇸 Fargo, North Dakota, United States