NIKP-Losartan HCTZ

NIKP-Losartan HCTZ Mechanism of Action

losartan + hydrochlorothiazide

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Full Prescribing Info
Action
Pharmacology: Phamacokinetics: Bioequivalence Study: When a single oral dose of one tablet of NIKP-Losartan HCTZ film-coated tablet 50mg/12.5mg or one tablet of the reference product (both tablets contain 50 mg of losartan potassium and 12.5mg of hydrochlorothiazide) was given to healthy male adults during fasting with a cross-over method, the plasma carboxylate form concentration* and hydrochlorothiazide concentration were measured. In a statistical analysis for the obtained pharmacokinetic parameters (AUC and Cmax), calculation results of 90% confidence intervals for the parameters were within a range between log (0.80) and log (1.25), demonstrating the bioequivalence of the two formulations.
(* Main active metabolites of losartan). (See Tables 1, 2 and Figures 1 and 2.)

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Plasma concentration and pharmacokinetic parameters such as AUC and Cmax may vary depending on study conditions including selection of subjects, body fluid sampling frequency/sampling time, etc.
Dissolution profile: This drug has been shown to meet the dissolution regulations for losartan potassium and hydrochlorothiazide tablets set forth in the Official Monographs of the Japanese Pharmacopoeia.
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