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

NCT ID: NCT01689285

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

Varicella Zoster Virus Infection; Herpes Simplex Virus Infection

Keywords

bioequivalence; pharmacokinetics; valacyclovir; paediatric formulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

valacyclovir tablet

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

Group Type: ACTIVE_COMPARATOR

valacyclovir tablet

Intervention Type: DRUG

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

valacyclovir oral solution

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

Group Type: EXPERIMENTAL

valacyclovir oral solution

Intervention Type: DRUG

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

Interventions

valacyclovir tablet

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

Intervention Type: DRUG

valacyclovir oral solution

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

Intervention Type: DRUG

Other Intervention Names

Zelitrex

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bas Schouwenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Medical Center

Nijmegen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 27162003 (View on PubMed)

Other Identifiers

UMCN-AKF 11.04

Identifier Type: -

Identifier Source: org_study_id