COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir (VALID-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01689285
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : September 3, 2015
Information provided by (Responsible Party):
Radboud University

Brief Summary:
A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.

Condition or disease Intervention/treatment Phase
Varicella Zoster Virus Infection Herpes Simplex Virus Infection Drug: valacyclovir tablet Drug: valacyclovir oral solution Phase 1

Detailed Description:
Bioequivalence of the new valcyclovir formulation will be tested according to the EMA guideline for bioequivalence.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of VZV and HSV Infections in Children, Phase I (VALID-I)
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: valacyclovir tablet
Administration of 500 mg once daily on day 1 (group A) or on day 8 (group B)
Drug: valacyclovir tablet
16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
Other Name: Zelitrex

Experimental: valacyclovir oral solution
Administration of 500 mg once daily on day 1 (group B) or on day 8 (group A)
Drug: valacyclovir oral solution
16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once

Primary Outcome Measures :
  1. Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic parameters of acyclovir taken as valacyclovir tablet or oral solution [ Time Frame: up to 8 days ]
    bioequivalence will be determined by comparing AUC0-inf, Cmax and tmax of both formulations in healthy adult volunteers.

Secondary Outcome Measures :
  1. Determine the safety profile of a single dose of valacyclovir oral solution [ Time Frame: day 1 and 8 ]
    healthy volunteers will be interviewed for adverse events, laboratory safety assessments will be performed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject is at least 18 and not older than 55 years of age at screening.
  • Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing
  • Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
  • Subject has signed the Informed Consent Form prior to screening evaluations.
  • Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
  • Subject has a normal blood pressure and pulse rate, according to the investigator's judgement.
  • Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or is of childbearing potential with adequate contraception (e.g. hysterectomy, bilateral tubal ligation, (nonhormonal) intrauterine device, total abstinence, double barrier methods, vasectomized partner).

Exclusion Criteria:

  • Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
  • Positive HIV, hepatitis B or C test.
  • Therapy with any drug (for two weeks preceding dosing), except for acetaminophen.
  • Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • History of or current abuse of drugs, alcohol or solvents.
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Participation in a drug trial within 60 days prior to the first dose.
  • Donation of blood within 60 days prior to the first dose.
  • Febrile illness within 3 days before the first dose.
  • Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01689285

Layout table for location information
Radboud University Medical Center
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Layout table for investigator information
Principal Investigator: Bas Schouwenberg, MD Radboud University
Layout table for additonal information
Responsible Party: Radboud University Identifier: NCT01689285    
Other Study ID Numbers: UMCN-AKF 11.04
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015
Keywords provided by Radboud University:
paediatric formulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Herpes Simplex
Herpes Zoster
Varicella Zoster Virus Infection
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents