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  • Ký hiệu PL/XG: 615
    Nhan đề: Khảo sát ảnh hưởng của thức ăn trên sinh khả dụng của viên kết hợp Metoprolol-Amlodipin 50/5 mg và xác định tương đương sinh học so với viên cùng hoạt chất SelomaxTM 50/5 /
DDC 615
Tác giả CN Nguyễn, Thị Linh Tuyền
Nhan đề Khảo sát ảnh hưởng của thức ăn trên sinh khả dụng của viên kết hợp Metoprolol-Amlodipin 50/5 mg và xác định tương đương sinh học so với viên cùng hoạt chất SelomaxTM 50/5 / Nguyễn Thị Linh Tuyền, Nguyễn Đức Tuấn, Lê Quan Nghiệm
Tóm tắt The film-coated tablets composed of sustained-release metoprolol 50 mg and intermediate release amlodipin 5 mg (metoprolol-amlodipine 50/5 mg) manufactured by Saigon Center for Science and Technology of Pharmacy were estimated for bioavailability in fast and fed conditions its bioequivalence to the reference SelomaxTM 50/5 in healthy volunteers. The bioavailability and bioequivalence of the two oral formulations were studied on 14 healthy volunteers by a single dose, two – treatment, two – period, three – sequence, randomized, crossover design with a two week washout period between the two phases of the study. After dosing, serial blood samples were collected for a period of 120 hours. Plasma harvested from blood was analyzed for metoprolol and amlodipine by liquid chromatography tandem-mass spectrometry (LC-MS/MS) (validated for a sensitivity, selectivity, reproductivity and accuracy). A set of pharmacokinetic parameters including AUC0-t, AUC0-∞, Cmax, Tmax and Ke were determined. No significant difference was observed in Cmax, AUC0-t, AUC0-∞, and Tmax of metoprolol of the test formulation dosed in fast and fed conditions. AUC0-t, AUC0-∞, and Cmax were tested for bioequivalence after Napier logarithm (Ln) – transform of data. No statistically significant difference was found by analysis of variance (ANOVA); 90% confidence interval for test/reference ratio of these parameters was found within bioequivalence acceptance range of 80 – 125%. These statistical inferences led to the conclusion that the two formulations were bioequivalent and the bioavailability of the test formulation were not influenced by food.
Thuật ngữ chủ đề Nghiên cứu - Kỹ thuật --Việt Nam
Từ khóa tự do Metoprolol-Amlodipin 50/5
Từ khóa tự do SelomaxTM 50/5
Tác giả(bs) CN Nguyễn, Đức Tuấn
Nguồn trích Tạp chí Dược học 2018tr. 17-19, 54 Số: 02
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100 |aNguyễn, Thị Linh Tuyền
245 |aKhảo sát ảnh hưởng của thức ăn trên sinh khả dụng của viên kết hợp Metoprolol-Amlodipin 50/5 mg và xác định tương đương sinh học so với viên cùng hoạt chất SelomaxTM 50/5 / |cNguyễn Thị Linh Tuyền, Nguyễn Đức Tuấn, Lê Quan Nghiệm
520 |aThe film-coated tablets composed of sustained-release metoprolol 50 mg and intermediate release amlodipin 5 mg (metoprolol-amlodipine 50/5 mg) manufactured by Saigon Center for Science and Technology of Pharmacy were estimated for bioavailability in fast and fed conditions its bioequivalence to the reference SelomaxTM 50/5 in healthy volunteers. The bioavailability and bioequivalence of the two oral formulations were studied on 14 healthy volunteers by a single dose, two – treatment, two – period, three – sequence, randomized, crossover design with a two week washout period between the two phases of the study. After dosing, serial blood samples were collected for a period of 120 hours. Plasma harvested from blood was analyzed for metoprolol and amlodipine by liquid chromatography tandem-mass spectrometry (LC-MS/MS) (validated for a sensitivity, selectivity, reproductivity and accuracy). A set of pharmacokinetic parameters including AUC0-t, AUC0-∞, Cmax, Tmax and Ke were determined. No significant difference was observed in Cmax, AUC0-t, AUC0-∞, and Tmax of metoprolol of the test formulation dosed in fast and fed conditions. AUC0-t, AUC0-∞, and Cmax were tested for bioequivalence after Napier logarithm (Ln) – transform of data. No statistically significant difference was found by analysis of variance (ANOVA); 90% confidence interval for test/reference ratio of these parameters was found within bioequivalence acceptance range of 80 – 125%. These statistical inferences led to the conclusion that the two formulations were bioequivalent and the bioavailability of the test formulation were not influenced by food.
650 |aNghiên cứu - Kỹ thuật |zViệt Nam
653 |aMetoprolol-Amlodipin 50/5
653 |aSelomaxTM 50/5
700 |aNguyễn, Đức Tuấn
773 |tTạp chí Dược học |d2018|gtr. 17-19, 54|i02
890|c1|a0|b0|d3
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