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)

This study has suspended participant recruitment.
(oral liquid was not available)
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01689285
First received: September 17, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Varicalle Zoster Virus Infection
Herpes Simplex Virus Infection
Drug: valacyclovir 500 mg tablet
Drug: valacyclovir oral solution 50 mg/ml
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir (VALID I)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 1 and 8 ] [ Designated as safety issue: Yes ]
    healthy volunteers will be interviewed for adverse events, laboratory safety assessments will be performed.


Estimated Enrollment: 16
Study Start Date: December 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: valacyclovir 500 mg tablet
once daily on day 1 (group A) or on day 8 (group B)
Drug: valacyclovir 500 mg tablet
16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
Other Name: Zelitrex
Experimental: valacyclovir oral solution 50 mg/ml
10 ml (500 mg) once daily on day 1 (group B) or on day 8 (group A)
Drug: valacyclovir oral solution 50 mg/ml
16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689285

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Bas Schouwenberg, MD Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01689285     History of Changes
Other Study ID Numbers: UMCN-AKF 11.04
Study First Received: September 17, 2012
Last Updated: August 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
bioequivalence
pharmacokinetics
valacyclovir
peadiatric formulation

Additional relevant MeSH terms:
Herpes Simplex
Herpes Zoster
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions
Valacyclovir
Acyclovir
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 31, 2014