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

Conditions

• Herpes Simplex Virus Infection
• Varicella Zoster Virus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• valacyclovir tablet — DRUG
  16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
• valacyclovir oral solution — DRUG
  16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once

Study Details

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.

Key Dates

Start date

Dec 31, 2013

Status verified

Dec 2020

Primary completion

Jul 31, 2015

Completion

Jul 31, 2015

Study Design

Enrollment

16 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Active Comparator: valacyclovir tablet
  Administration of 500 mg once daily on day 1 (group A) or on day 8 (group B)
• Experimental: valacyclovir oral solution
  Administration of 500 mg once daily on day 1 (group B) or on day 8 (group A)

Primary Outcome Measure

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 ]