Pharmacokinetic dose-proportionality study at steady state of mirtazapine from Remeron® tablets
✍ Scribed by C. J. Timmer; A. A. M. Lohmann; C. P. A. Mink
- Publisher
- John Wiley and Sons
- Year
- 1995
- Tongue
- English
- Weight
- 735 KB
- Volume
- 10
- Category
- Article
- ISSN
- 0885-6222
No coin nor oath required. For personal study only.
✦ Synopsis
Steady-state dose proportionality of mirtazapine, the active constituent of Remeronm tablets, a new antidepressant developed under the laboratory code Org 3770, was investigated. Each of 27 young healthy male subjects received a single daily oral dose of mirtazapine in the form of standard Remeronm tablets, beginning with 15 mg per day and advancing at five-day intervals to the next higher dose. The oral doses of mirtazapine were 15, 30, 45, 60 and 75 mg per day. Serial blood samples were taken on the fifth day of each dosing period and at several other times in order to check whether the steady state had been reached. In addition, blood samples were taken up to 120 hours after the last dose of 75mg in order to accurately determine the elimination half-life. Plasma levels of mirtazapine were determined by capillary gas chromatography with nitrogen sensitive detection. Pharmacokinetic parameters were calculated from the plasma mirtazapine levels and subjected to analysis of variance.
The steady state was attained on the fifth day of each dosing period. Pharmacokinetics of mirtazapine was found to be essentially linear in the dose range studied. Mean f SD of the elimination half-life were accurately determined as 21.5k5.0h (n=27), range 13.1-33.6h.