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.
Bioequivalence of the new valcyclovir formulation will be tested according to the EMA guideline for bioequivalence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once
Radboud University Medical Center
Nijmegen, Netherlands
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.
Time frame: up to 8 days
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.
Time frame: day 1 and 8
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