건강한 남성 자원자에서 탐스로신의 공복 투여 시항정상태의 약동학적 특성 연구
- 건강한 남성 자원자에서 탐스로신의 공복 투여 시항정상태의 약동학적 특성 연구
- Other Titles
- Steady-State Pharmacokinetic Properties of Tamsulosin in Healthy Male Volunteers
- 임미선; 성숙진[성숙진]; 이혜원[이혜원]; 이주미[이주미]; 김은희[김은희]; 박성민[박성민]; 권미리[권미리]; 윤영란[윤영란]
- 탐스로신; 반복투여; 약동학; 공복 상태; 건강한 자원자; Fasted state; Healthy volunteers; Multiple-dose; Pharmacokinetics; Tamsulosin
- Issue Date
- Translational and Clinical Pharmacology, v.21, no.2, pp.130 - 140
- Background: To evaluate the pharmacokinetic properties of daily oral doses of tamsulosin administered to fasted healthy Korean male volunteers for 5 days.
Methods: In a randomized, open-label, multiple-dose, two-period, crossover study, all 44 subjects were randomly assigned in a 1:1 ratio to receive a newly developed generic capsule formulation (test) or a branded capsule formulation (reference) of tamsulosin 0.2 mg, followed by a 10-day washout period and administration of the other formulation. Plasma concentrations of tamsulosin were assessed after administration of five-day multiple doses, using HPLC-MS/MS. Clinical and laboratory adverse events (AE) were assessed.
Results: The mean (SD) pharmacokinetic properties with the test and reference formulations were as follows: Css,max , 9.0 (2.9) and 8.4 (2.6) ng/mL, respectively; median (range) tmax, 4 (2-6) and 5 (2-7) hours; AUCτ, 93.7 (31.5) and 88.2 (29.3) ng × h/mL; and t½, 9.5 (2.6) and 10.0 (2.7) hours. The volume of distribution and clearance after oral administration of tamsulosin were 0.5 L/kg, and 0.04 L/h/kg, respectively. The accumulation ratios for 0.2 mg once-daily dosing regimen were 1.2. The 90% CIs of the geometric mean ratios for the log-transformed AUCτ (1.005-1.131) and Css,max (1.000-1.136) values were within the acceptable range for bioequivalence. No serious AE was reported during the study. Both formulations were well tolerated.
Conclusion: The results demonstrate that the Css,max and AUCτ values in the fasted subjects were higher than those in the fed from other study, with a shorter tmax values.
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