Pharmacokinetics of Moclobemide Sustained Release Tablets after Multiple Oral Dose Administration in Healthy Volunteers

Abstract

Abstract: Aim To investigate the pharmacokinetic characteristics of moclobemide sustained release tablets after multiple oral dose administration in healthy Chinese volunteers. Methods Moclobemide sustained release tablets were given as a multiple oral dose regimen of 300 mg once daily for five consecutive days to 12 healthy volunteers. The concentrations of moclobemide in plasma were determined by reversed-phase high performance liquid chromatography. The partial pharmacokinetic parameters were calculated using 3p97 pharmacokinetic program. Results The concentration-time profile fitted an one-compartment model best. The steady-state pharmacokinetic parameters of moclobemide sustained release tablets after multiple oral doses were as follows: Cmax was (1 950±156)μg·L^-1, Tmax was (6.00±1.55) h, T1/2(kel) was (3.14±0.12) h, AUCss0-24 was (22836±1842) μg·h·L^-1, MRT was (7.68±0.36) h, CL/F(s) was (20.2±2.1) L·h^-1, and V/F(c) was (91.4±9.4) L, respectively. No marked adverse events were noted during this study. Conclusion The formulation has a sustained-release effect and good tolerance in the healthy volunteers, which provides useful information for clinical practice.

Key words: moclobemide sustained release tablets, moclobemide sustained release tablets, high performance liquid chromatography, high performance liquid chromatography, pharmacokinetics, pharmacokinetics, multiple dose, multiple dose

CLC Number:

R944.4

R969.11

Supporting:

HU Dao-de^*, MAO Dan-zhuo, PEI Yuan-ying. Pharmacokinetics of Moclobemide Sustained Release Tablets after Multiple Oral Dose Administration in Healthy Volunteers[J]. .

References

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