NIKP-Zolpidem

NIKP-Zolpidem Mechanism of Action

zolpidem

Manufacturer:

Nichi-Iko

Distributor:

DKSH
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Action
Pharmacology: Pharmacokinetics: Bioequivalence Study: When a single oral dose of one tablet of NIKP-Zolpidem tablet 10 mg or one tablet of the reference product (both tablets contain 10 mg of zolpidem tartrate) was given to healthy male adults during fasting with a cross-over method, the plasma concentrations of zolpidem 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 (0.8) and log (1.25), demonstrating the bioequivalence of the two formulations. (See Table 1 and figure.)

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Dissolution Profile: This drug has been shown to meet the dissolution specification for zolpidem tartrate tablets set forth in the Official Monographs of the Japanese Pharmacopoeia.
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