Bioequivalence study of two mirtazapine oral tablet formulations in healthy Chinese male volunteers.
Summary of "Bioequivalence study of two mirtazapine oral tablet formulations in healthy Chinese male volunteers."
Objective: Mirtazapine is a tetracyclic antidepressant which works relating to noradrenergic and elective serotoninergic receptors. The aim of this study was to assess the pharmacokinetic properties and bioequivalence of a newly developed tablet formulation of mirtazapine with those of an established branded formulation in healthy Chinese male volunteers. Materials and methods: A randomized, open-label, single-dose, 2-way crossover study was conducted in healthy Chinese volunteers under fasting conditions with a washout of 14 days between the study periods. A sensitive and credible high-performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) method was developed and validated to determine mirtazapine in human plasma. Results: The main PK parameters of the mirtazapine test and reference tables were as follows: mean (SD) Cmax, 58.715 (23.89) and 58.255 (22.34) ng/ml; AUC0-t, 591.406 (186.79) and 596.339 (201.25) ng × h/ml; AUC0-∞, 627.03 (201.39) and 631.521 (227.32) ng × h/ml; t1/2, 18.941 (4.79) and 18.285 (3.91) h; tmax 1.417 (0.61) and 1.424 (0.75) h. The 90% CI for logtransformed ratios of Cmax (88.8 - 112.4%), AUC0-t (93.9 - 104.9%) and AUC0-∞ (94.5 - 105.3%) for the test and reference formulations respectively, meeting the predetermined criteria for bioequivalence. Conclusions: Both treatments exhibited similar tolerability and safety. The test product is therefore bioequivalent to the reference product with respect to the rate and extent of mirtazapine pharmacokinetics.
Affiliation
Institute of Clinical Pharmacology, West China Hospital, Sichuan University, Chengdu, China.
Journal Details
This article was published in the following journal.
Name: International journal of clinical pharmacology and therapeutics
ISSN: 0946-1965
Pages: 368-74
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22541842
- DOI: http://dx.doi.org/
Medical and Biotech [MESH] Definitions
Epidemiologic Study Characteristics As Topic
Types and formulations of studies used in epidemiological and clinical research.
Evodia
A plant genus of the family RUTACEAE which is used in Chinese medicine (DRUGS, CHINESE HERBAL). Evodiamine and other quinazoline alkaloids (QUINAZOLINES) are obtained from the fruit of E. ruticarpa.
Oral Medicine
A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)
Cinnamomum Aromaticum
A plant species of the genus CINNAMOMUM that contains CINNAMATES and has been used in traditional Chinese medicine (DRUGS, CHINESE HERBAL).
Yang Deficiency
In the YIN-YANG system of philosophy and medicine, a lack of vital energy (called yangxu in Chinese). It manifests itself in various systemic and organic diseases. (The Pinyin Chinese-English Dictionary, 1979)
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