Healthy Clinical Trial
Official title:
Bioequivalence Study of 160 mg Valsartan Film-coated Caplets Produced by PT Dexa Medica in Comparison With the Innovator Film-coated Tablets (Diovan® 160, Novartis Pharma AG)
This was a randomized, single-blind, two-period, two sequence cross-over study under fasting condition, with a one-week wash-out period, to compare the pharmacokinetic profiles and bioavailability of two formulations (the test and reference) of valsartan 160 mg film-coated caplets.
In the first period, subjects received either the test formulation (160 mg valsartan
film-coated caplets produced by PT Dexa Medica, Palembang, Indonesia) once daily, or the
innovator film-coated tablets (Diovan® 160, Novartis Farmaceutica S.A., Barbera del Valles,
Spain for Novartis Pharma AG, Basel, Switzerland) once daily as the reference formulation.
In the subsequent period, after a one-week wash-out period, they received the alternate
drug.
At the night before starting the study, subjects were instructed to fast from any food and
drink but mineral water for 9 hours before the drug administration. In the morning after, at
the dosing day, each of the 48 subjects then swallowed (without chewing) one dose of
valsartan 160 mg of the test formulation or of the reference formulation, with 200 mL of
water. As much as 5 mL of blood samples for drug assay were drawn again from each subject,
at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 16, 24, 36, and 48 hours after dosing.
The concentrations of valsartan in plasma were assayed using a validated high performance
liquid chromatography with fluorescence detector (HPLC-FL) method. Pharmacokinetic
parameters, including the area under the concentration-versus-time curve (AUC) from time
zero to the time of last quatifiable concentration (48 hours after dosing) (AUC-t), AUC from
time zero extrapolated to infinity (AUC-inf), maximum concentration (Cmax), time to reach
the maximum concentration (tmax), and half-life (t1/2), were assessed in this study.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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