Pharmacokinetics of loratadine in loratadine, paracetamol and pseudoephedrine sustained-release tablets in healthy volunteers
- VernacularTitle:氯酚伪麻缓释片中氯雷他定在健康志愿者体内的药动学(英文)
- Author:
Rongshan LI
;
Xiaofeng GUO
;
Yanwen ZHANG
- Publication Type:Journal Article
- From:
Chinese Journal of New Drugs and Clinical Remedies
2007;26(11):801-804
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To study the pharmacokinetics of loratadine in healthy volunteers after single and multiple oral administrations of loratadine, paracetamol and pseudoephedrine (LPP) sustained-release tablets.METHODS: Twenty-four volunteers were randomized into two groups which included six men and six women in each group. In the single dose design, volunteers received either one or two tablet (s) of LPP. After 1 wk wash out period, volunteers of one tablet group participated in multiple dose design in which each volunteer received one tablet of LPP twice per day for six consecutive days. The concentrations of loratadine in plasma were determined by HPLC-MS method and the pharmacokinetic parameters were calculated. RESULTS: In the single dose design, main pharmacokinetic parameters of one and two tablet group were as follow: cmax were ( 1.5 ±groups were similar to each other. The obtained multi-dose pharmacokinetic parameters were as follows: AUCssrespectively. D (F) was (3.3 ± 0.8) %. The pharmacokinetics of loratadine was linear. There were no significant difference in pharmacokinetics between single-dose and multi-dose. CONCLUSION: The release and absorption of loratadine in experimental tablet are close to those in loratadine tablet and not affected by the other two components, pseudoephedrine and paracetamol, in LPP sustained release tablet.