NCT01132716

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

Same day

First QC Date

May 25, 2010

Last Update Submit

January 19, 2018

Conditions

Herpes ZosterShinglesGenital Herpes

Outcome Measures

Primary Outcomes (1)

  • bioequivalence determined by statistical comparison Cmax

    8 days

Interventions

Valacyclovir HydrochlorideDRUG

1000 mg caplet

Also known as: Valtrex

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRACs Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Herpes ZosterHerpes Genitalis

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesHerpes SimplexGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Alan Copa, PharmD

    PRACs Institute, Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 28, 2010

Study Start

September 1, 2006

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)