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

Primary Purpose

Varicella Zoster Virus Infection, Herpes Simplex Virus Infection

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
valacyclovir tablet
valacyclovir oral solution
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Varicella Zoster Virus Infection focused on measuring bioequivalence, pharmacokinetics, valacyclovir, paediatric formulation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

valacyclovir tablet

valacyclovir oral solution

Arm Description

Administration of 500 mg once daily on day 1 (group A) or on day 8 (group B)

Administration of 500 mg once daily on day 1 (group B) or on day 8 (group A)

Outcomes

Primary Outcome Measures

Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic parameters of acyclovir taken as valacyclovir tablet or oral solution
bioequivalence will be determined by comparing AUC0-inf, Cmax and tmax of both formulations in healthy adult volunteers.

Secondary Outcome Measures

Determine the safety profile of a single dose of valacyclovir oral solution
healthy volunteers will be interviewed for adverse events, laboratory safety assessments will be performed.

Full Information

First Posted
September 17, 2012
Last Updated
December 4, 2020
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01689285
Brief Title
Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir
Acronym
VALID-I
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 Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella Zoster Virus Infection, Herpes Simplex Virus Infection
Keywords
bioequivalence, pharmacokinetics, valacyclovir, paediatric formulation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
valacyclovir tablet
Arm Type
Active Comparator
Arm Description
Administration of 500 mg once daily on day 1 (group A) or on day 8 (group B)
Arm Title
valacyclovir oral solution
Arm Type
Experimental
Arm Description
Administration of 500 mg once daily on day 1 (group B) or on day 8 (group A)
Intervention Type
Drug
Intervention Name(s)
valacyclovir tablet
Other Intervention Name(s)
Zelitrex
Intervention Description
16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
Intervention Type
Drug
Intervention Name(s)
valacyclovir oral solution
Intervention Description
16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once
Primary Outcome Measure Information:
Title
Geometric Mean Ratios and 90% confidence intervals of pharmacokinetic parameters of acyclovir taken as valacyclovir tablet or oral solution
Description
bioequivalence will be determined by comparing AUC0-inf, Cmax and tmax of both formulations in healthy adult volunteers.
Time Frame
up to 8 days
Secondary Outcome Measure Information:
Title
Determine the safety profile of a single dose of valacyclovir oral solution
Description
healthy volunteers will be interviewed for adverse events, laboratory safety assessments will be performed.
Time Frame
day 1 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bas Schouwenberg, MD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27162003
Citation
Bastiaans DE, Bartels-Wilmer CM, Colbers AP, Heijens CA, Velthoven-Graafland K, Smeets OS, Vink N, Harbers VE, Warris A, Burger DM. A new paediatric formulation of valaciclovir: development and bioequivalence assessment. Arch Dis Child. 2016 Oct;101(10):971-2. doi: 10.1136/archdischild-2015-310266. Epub 2016 May 9. No abstract available.
Results Reference
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Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

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