The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product, Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)
Twenty-eight healty subjects were given a single dose of acyclovir tablet or Zovirax® in dosage form 200 mg and 400mg with 240 mL of water. Then the blood samples for acyclovir was drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
Administered with 240 mL of water
Administered with 240 mL of water
Administered with 240 mL of water
PT Pharma Metric Labs
Jakarta Pusat, DKI Jakarta, Indonesia
Pharmacokinetics Parameter
Maximum plasma concentration (Cmax)
Time frame: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
Pharmacokinetics Parameter
Area Under Curve from 0 to 24 hours (AUCt)
Time frame: Predose at (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose
Geometric Mean Ratio
The ratio between maximum concentration of test drug and reference drug after drug administration
Time frame: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
Geometric Mean Ratio
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
Time frame: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Administered with 240 mL of water