NIKP-Losartan

NIKP-Losartan Mechanism of Action

losartan

Manufacturer:

Nichi-Iko

Distributor:

DKSH
Full Prescribing Info
Action
Pharmacology: Pharmacokinetics: Bioequivalence Study: When a single oral dose of one tablet of NIKP-Losartan tablet 25mg or one tablet of the reference product (both tablets contain 25 mg of losartan potassium) was given to healthy male adults during fasting with a cross-over method, the plasma concentration of active metabolite carboxylate form was 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.
Similarly, the results of administration of one tablet of NIKP-Losartan tablet 50mg or one tablet of the reference product (both tablets contain 50 mg of losartan potassium) and one tablet of NIKP-Losartan tablet 100mg or one tablet of the reference product (both tablets contain 100 mg of losartan potassium) showed bioequivalence between the two formulations. (See Tables 1,2,3 and Figures 1,2 and 3.)

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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 behavior: NIKP-Losartan tablet 50mg and 100mg have been shown to meet the dissolution regulations for "Losartan Potassium Tablets" set forth in the Official Monographs of the Japanese Pharmacopoeia.
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