Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir

NCT01689285 | Completed Phase 1

• 1 other identifier: UMCN-AKF 11.04
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicella Zoster Virus Infection; Herpes Simplex Virus Infection

Keywords

bioequivalence; pharmacokinetics; valacyclovir; paediatric formulation

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 8 days

Secondary Outcomes (1)

• Determine the safety profile of a single dose of valacyclovir oral solution

  day 1 and 8

Study Arms (2)

valacyclovir tablet

ACTIVE COMPARATOR

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

Drug: valacyclovir tablet

valacyclovir oral solution

EXPERIMENTAL

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

Drug: valacyclovir oral solution

Interventions

valacyclovir tablet DRUG

16 healthy adult volunteers (18-55 yr) will be exposed to one tablet

Also known as: Zelitrex

valacyclovir tablet

valacyclovir oral solution DRUG

16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once

valacyclovir oral solution

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 27162003 RESULT

MeSH Terms

Conditions

Varicella Zoster Virus Infection; Herpes Simplex

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bas Schouwenberg, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 21, 2012
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

NL (1)