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CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service, 2024, 42(12): 524-527, 532. doi: 10.12206/j.issn.2097-2024.202405035
Citation:
ZHU Leilei, GUO Lixia, ZHAN Yan, QIU Furong, ZHAO Tongfang, YE Yujie, YUAN Wei'an, LI Anping, LI Minghua, SU Shufang, JIANG Jian. Bioequivalence study on two terazosin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009
Bioequivalence study on two terazosin hydrochloride tablets
Department of Clinical Pharmacology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
2.
Shanghai Center for Drug Metabolism and Pharmacokinetics Research, Shanghai 201203, China
3.
Shanxi Zhendong Pharmaceutical Co., Ltd., Changzhi 460000, China
Received Date: 2014-09-26
Rev Recd Date:
2015-03-31
Abstract
Objective To evaluate the bioequivalence of domestic and imported terazosin hydrochloride tablets after single oral dose. Methods It was a single center, randomized, open, cross-over trail design, 21 subjects were fasting oral administered of 2 mg domestic and imported terazosin hydrochloride tablets in different periods, venous blood 4 ml were collected in different time points before and 60 h after administration, plasma concentration of terazosin was determined by LC-MS/MS. Results The main pharmacokinetic parameters of domestic and imported terazosin hydrochloride tablets were as follows:t1/2 : (13.2± 2.39) h vs (12.5±1.93) h, tmax: (1.01±0.83) h vs (1.08±0.69) h, Cmax: (40.1±10.6) ng/ml vs (37.3±9.57) ng/ml; AUC0- ∞: (428±82.1) ng·h/ml vs (426±85.2) ng·h/ml. The relative bioavailability of domestic terazosin hydrochloride tablets was (101.2±14.7)%. 90% CI of domestic and imported terazosin hydrochloride tablets AUC0-t and Cmax geometric mean ratio fell between 80%-125%. Conclusion The domestic tablets are bioequivalent to the imported tablets.
Abstract: Objective To evaluate the bioequivalence of domestic and imported terazosin hydrochloride tablets after single oral dose. Methods It was a single center, randomized, open, cross-over trail design, 21 subjects were fasting oral administered of 2 mg domestic and imported terazosin hydrochloride tablets in different periods, venous blood 4 ml were collected in different time points before and 60 h after administration, plasma concentration of terazosin was determined by LC-MS/MS. Results The main pharmacokinetic parameters of domestic and imported terazosin hydrochloride tablets were as follows:t1/2 : (13.2± 2.39) h vs (12.5±1.93) h, tmax: (1.01±0.83) h vs (1.08±0.69) h, Cmax: (40.1±10.6) ng/ml vs (37.3±9.57) ng/ml; AUC0- ∞: (428±82.1) ng·h/ml vs (426±85.2) ng·h/ml. The relative bioavailability of domestic terazosin hydrochloride tablets was (101.2±14.7)%. 90% CI of domestic and imported terazosin hydrochloride tablets AUC0-t and Cmax geometric mean ratio fell between 80%-125%. Conclusion The domestic tablets are bioequivalent to the imported tablets.
CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service, 2024, 42(12): 524-527, 532. doi: 10.12206/j.issn.2097-2024.202405035
Citation:
ZHU Leilei, GUO Lixia, ZHAN Yan, QIU Furong, ZHAO Tongfang, YE Yujie, YUAN Wei'an, LI Anping, LI Minghua, SU Shufang, JIANG Jian. Bioequivalence study on two terazosin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2015, 33(5): 419-422. doi: 10.3969/j.issn.1006-0111.2015.05.009
CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service, 2024, 42(12): 524-527, 532. doi: 10.12206/j.issn.2097-2024.202405035
CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service, 2024, 42(12): 524-527, 532. doi: 10.12206/j.issn.2097-2024.202405035
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